ObesityHIIT&PUFANCT05295719
Combining HIIT and n-3 PUFA to Reduce Inflammation and Improve Metabolic Health
A study testing Omega-3 polyunsaturated fatty acid, High-Intensity Interval Training and Safflower oil in people with Obesity and Inflammation, run by Texas Tech University at 1 site in United States.
Trial summary
The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Inflammation, Human Microbiome
- What is being tested?
- Omega-3 polyunsaturated fatty acid, High-Intensity Interval Training and Safflower oil
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Overweight/ Obese (BMI ≥ 25 to ≤ 40 kg/m2)
- Elevated Triglycerides (>150 mg/dL)
- Prediabetes (fasting blood glucose 100 to 125 mg/dl)
Who cannot join
- Diagnosed with Diabetes or liver disease.
- Taking BP or diabetes medications.
- Received antibiotics medications in the last 6 months.
- Pregnant/ lactating/ Irregular menstrual cycle/ menopausal.
- Currently following a formal/ structured weight loss program.
- Currently taking fish oil.
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- Do not have access to smart phone/ computer with internet access.
- Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire.
- Feeling uncomfortable riding bike for 30 minutes.
- Claustrophobic or unable to stay under the hood for metabolic testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech Kinesiology Building
Lubbock, Texas, 79406
About this study
Official title: Combining Fish Oil and Exercise to Improve Obesity-associated Inflammation
The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.
Read the detailed description
Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative to understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk. These studies will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia.
The first aim of this study will focus on determining the combined effects of n-3 PUFA and HIIT on improving metabolic risks such as obesity-related markers of inflammation, dyslipidemia, and insulin resistance.
The investigators will test the hypothesis that n-3 PUFA, in addition to HIIT, will have beneficial effects on energy utilization, as well as obesity-related markers of inflammation, dyslipidemia and insulin resistance.
Aim 2.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition Aim 2.2: Investigate the influence of n-3 PUFA and HIIT on serum markers associated with obesity Aim 2.3: Investigate influence of n-3 PUFA and HIIT on energy utilization/ markers of insulin resistance
The second aim is to determine the combined effects of n-3 polyunsaturated fatty acids (n-3 PUFA) and high-intensity interval training (HIIT) on improving gut dysbiosis.
The investigators will test the hypothesis that n-3 PUFA supplementation will improve gut microbiota composition and related metabolites, which will result in reduced inflammation and ameliorate the metabolic response to a HIIT exercise intervention in an overweight population.
Aim 1.1: Investigate the influence of n-3 PUFA and exercise on gut microbiota composition
Aim 1.2: Investigate the influence of n-3 PUFA and exercise on microbiota produced metabolites
Participants will be randomly allocated to 1 of 4 treatment groups (n = 120), each balanced for sex, BMI, lipid profile, and dietary intake. The goal is to conduct the study in smaller cohorts, such as 10-15 participants/group (n = 40-60).
Participants will first be allocated to two groups: One group will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) and one group will take placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) for 4 weeks of initial supplementation.
Following this, one group from the treatment and one from the placebo group (creating 4 groups: (1) placebo + low-intensity training (LIT); (2) n-3 PUFA + LIT; (3) placebo + HIIT; (4) n-3 PUFA + HIIT) will also participate in a 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program utilizing cycle ergometers on 3 days/week conducted in the research lab and under investigator supervision for 4 weeks while continuing supplementation.
If not asked to exercise, participants will be instructed to maintain their normal level of physical activity but will participate in a time-matched session of low-intensity training (50% HRmax) on 3 days/week conducted in the research lab and under investigator supervision.
All participants will wear a heart rate monitor (Polar H10) provided by TTU throughout the training (HIIT and LIT) to monitor exertion level.
Capsules will be administered in a double-blind fashion and will be identical in appearance. Participants will visit the clinic to pick up capsules. To ensure compliance, subjects will be reminded via phone (text message or phone call based on participant preference) to take their capsules and counts will be conducted when they come in for study visits.
As with any acute metabolic or physiological improvements, beneficial effects of exercise on bacterial taxa and resultant metabolite production are quickly reversed with detraining. Thus, it is of interest to determine if fish consumption can ameliorate the negative metabolic and gut effects of detraining.
At the end of the 4-week intervention (week 8), participants will cease engaging in HIIT or LIT for a 2-week detraining period. Participants will continue taking their assigned supplements.
- Conditions
- Obesity, Inflammation, Human Microbiome, Insulin Resistance, Dyslipidemias
- Being tested
- Omega-3 polyunsaturated fatty acid, High-Intensity Interval Training, Safflower oil, Low-intensity training
- Medical subject headings
- Obesity, Inflammation, Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 polyunsaturated fatty acidDietary supplement
Also called AlaskOmega
4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA)
High-Intensity Interval TrainingBehavioural
Also called HIIT
A 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max.
Safflower oilDietary supplement
Also called Placebo
4 grams safflower oil (AlaskOmega®) per day
Low-intensity trainingBehavioural
A low-intensity training exercise program 3 days/week for 4 weeks. This will include consistently cycling at 50% HRmax for 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Placebo & Flexibility Training (Control) | Placebo comparator | Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in low-intensity training (control group) for 30 minutes 3 times/week for 4 weeks. All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and will cease low-intensity training for a 2 week follow-up period. Receives: Dietary Supplement: Safflower oil; Behavioral: Low-intensity training |
| Placebo & High-Intensity Interval Training | Active comparator | Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease HIIT training for a 2 week follow-up period. Receives: Behavioral: High-Intensity Interval Training; Dietary Supplement: Safflower oil |
| n-3 PUFA & Flexibility Training (Control) | Active comparator | Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in low-intensity training (control group) for 30 minutes 3 times/week for 4 weeks. All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease low-intensity training for a 2 week follow-up period. Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acid; Behavioral: Low-intensity training |
| n-3 PUFA & High-Intensity Interval Training | Experimental | Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease low-intensity training for a 2 week follow-up period. Receives: Dietary Supplement: Omega-3 polyunsaturated fatty acid; Behavioral: High-Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 4 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Interleukin (IL)-6 at 4 weeks
Interleukin (IL)-6 (pg/mL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Interleukin (IL)-10 at 4 weeks
Interleukin (IL)-10 (pg/mL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 4 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Tumor necrosis factor at 4 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Total Cholesterol at 4 weeks
Total cholesterol (mg/dL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in High-density lipoprotein (HDL)at 4 weeks
High-density lipoprotein (HDL) (mg/dL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 4 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Low-density lipoprotein (LDL) at 4 weeks
Low-density lipoprotein (LDL) (mg/dL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 4 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Triglycerides at 4 weeks
Triglycerides (mg/dL).
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Total/HDL cholesterol at 4 weeks
Total/HDL cholesterol (mg/dL)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Fasting blood glucose at 4 weeks
Fasting blood glucose (mg/dL)
Measured: Post-supplementation at week 4
Mean Change from Baseline in Insulin at 4 weeks
Insulin (μU/mL)
Measured: Post-supplementation at week 4
Mean Change from Baseline in Total Body Fat Percentage at 4 weeks
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Body Weight at 4 weeks
Body weight (kilograms)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 4 weeks
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks
Interleukin (IL)-6 (pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks
Interleukin (IL)-10 (pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Tumor necrosis factor (TNF) at 8 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Total Cholesterol at 8 weeks
Total Cholesterol (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in High-density lipoprotein (HDL) at 8 weeks
High-density lipoprotein (HDL) (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Measured: Post-intervention at week 8
Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks
Low-density lipoprotein (LDL) (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Triglycerides at 8 weeks
Triglycerides (mg/dL).
Measured: Post-Intervention at week 8
Mean Change from Baseline in total/HDL cholesterol at 8 weeks
Total/HDL cholesterol (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Fasting blood glucose at 8 weeks
Fasting blood glucose (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks
Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
Measured: Post-Intervention at week 8
Mean Change from Baseline in Insulin at 8 weeks
Insulin (μU/mL)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Body Weight at 8 weeks
Body weight (kilograms)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Total Body Fat Percentage at 8 weeks
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Measured: Post-Intervention at week 8
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Measured: Post-Intervention at week 8
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 10 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Interleukin (IL)-6 at 10 weeks
Interleukin (IL)-6 (pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Interleukin (IL)-10 at 10 weeks
Interleukin (IL)-10 (pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Tumor necrosis factor (TNF) at 10 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 10 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Total Cholesterol at 10 weeks
Total Cholesterol (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in High-density lipoprotein (HDL) at 10 weeks
High-density lipoprotein (HDL) (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Low-density lipoprotein (LDL) at 10 weeks
Low-density lipoprotein (LDL)(mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 10 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Total/HDL cholesterol at 10 weeks
Total/HDL cholesterol (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Triglycerides at 10 weeks
Triglycerides (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Insulin at 10 weeks
Insulin (μU/mL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Fasting blood glucose at 10 weeks
Fasting blood glucose (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 10 weeks
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Measured: Post-Detraining at week 10
Mean Change from Baseline in Body weight at 10 weeks
Body weight (kilograms)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Total Body Fat Percentage at 10 weeks
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Measured: Post-Detraining at week 10
Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 8 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Interleukin (IL)-6 at 8 weeks
Interleukin (IL)-6 (pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Interleukin (IL)-10 at 8 weeks
Interleukin (IL)-10 (pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 8 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 8 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Total Cholesterol at 8 weeks
Total Cholesterol (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Total/HDL cholesterol at 8 weeks
Total/HDL cholesterol (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 8 weeks
High-density lipoprotein (HDL) (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 8 weeks
Low-density lipoprotein (LDL) (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 8 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Triglycerides at 8 weeks
Triglycerides (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Insulin at 8 weeks
Insulin (μU/mL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Fasting blood glucose at 8 weeks
Fasting blood glucose (mg/dL)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Body weight at 8 weeks
Body weight (kilograms)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Total Body Fat Percentage at 8 weeks
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Measured: Post-Intervention at week 8
Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 10 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 10 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Interleukin (IL)-6 at 10 weeks
Interleukin (IL)-6 (pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Interleukin (IL)-10 at 10 weeks
Interleukin (IL)-10 (pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 10 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Total Cholesterol at 10 weeks
Total Cholesterol (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 10 weeks
High-density lipoprotein (HDL) (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 10 weeks
Low-density lipoprotein (LDL) (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 10 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Total/HDL cholesterol at 10 weeks
Total/HDL cholesterol (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Triglycerides at 10 weeks
Triglycerides (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Insulin at 10 weeks
Insulin (μU/mL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Fasting blood glucose at 10 weeks
Fasting blood glucose (mg/dL)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Body weight at 10 weeks
Body weight (kilograms)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Total Body Fat Percentage at 10 weeks
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 10 weeks
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Measured: Post-Detraining at week 10
Secondary outcomes (35)
Mean Change from Baseline in Bacterial Profile at 4 weeks
Fecal Microbial DNA (16s Sequencing)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Serum Acetate Profile at 4 weeks
Serum Acetate (SCFA: gas chromatography analysis)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Fecal acetate Profile at 4 weeks
Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Propionate Profile at 4 weeks
Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Butyrate Profile at 4 weeks
Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Markers of Serum lipopolysaccharides at 4 weeks
Serum lipopolysaccharides (LPS, ng/ml)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 4 weeks
Serum lipopolysaccharides-binding protein (LBP, pg/ml)
Measured: Post-Supplementation at week 4
Mean Change from Baseline in Bacterial Profile at 8 weeks
Fecal Microbial DNA (16s Sequencing)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Serum Acetate Profile at 8 weeks
Serum Acetate (SCFA: gas chromatography analysis)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Fecal acetate Profile at 8 weeks
Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Intervention at week 8
Mean Change from Baseline in Propionate Profile at 8 weeks
Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Intervention at week 8
Mean Change from Baseline in Butyrate Profile at 8 weeks
Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Intervention at week 8
Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks
Serum lipopolysaccharides (LPS, ng/ml)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks
Serum lipopolysaccharides-binding protein (LBP, pg/ml)
Measured: Post-Intervention at week 8
Mean Change from Baseline in Serum Acetate Profile at 10 weeks
Serum Acetate (SCFA: gas chromatography analysis)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Fecal acetate Profile at 10 weeks
Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Detraining at week 10
Mean Change from Baseline in Bacterial Profile at 10 weeks
Fecal Microbial DNA (16s Sequencing)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Propionate Profile at 10 weeks
Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Detraining at week 10
Mean Change from Baseline in Butyrate Profile at 10 weeks
Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Detraining at week 10
Mean Change from Baseline in Markers of Serum lipopolysaccharides at 10 weeks
Serum lipopolysaccharides (LPS, ng/ml)
Measured: Post-Detraining at week 10
Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 10 weeks
Serum lipopolysaccharides-binding protein (LBP, pg/ml)
Measured: Post-Detraining at week 10
Mean Change from Post-Supplementation in Bacterial Profile at 8 weeks
Fecal Microbial DNA (16s Sequencing)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Serum Acetate Profile at 8 weeks
Serum Acetate (SCFA: gas chromatography analysis)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Fecal acetate Profile at 8 weeks
Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Propionate Profile at 8 weeks
Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Butyrate Profile at 8 weeks
Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 8 weeks
Serum lipopolysaccharides (LPS, ng/ml)
Measured: Post-Intervention at week 8
Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 8 weeks
Serum lipopolysaccharides-binding protein (LBP, pg/ml)
Measured: Post-Intervention at week 8
Mean Change from Post-Intervention in Bacterial Profile at 10 weeks
Fecal Microbial DNA (16s Sequencing)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Serum Acetate Profile at 10 weeks
Serum Acetate (SCFA: gas chromatography analysis)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Fecal acetate Profile at 10 weeks
Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Propionate Profile at 10 weeks
Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Butyrate Profile at 10 weeks
Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 10 weeks
Serum lipopolysaccharides (LPS, ng/ml)
Measured: Post-Detraining at week 10
Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 10 weeks
Serum lipopolysaccharides-binding protein (LBP, pg/ml)
Measured: Post-Detraining at week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, Texas Tech University Health Sciences Center
- Responsible party
- Principal investigator, Kembra Albracht, Texas Tech University
- Investigators
- Kembra D Albracht-Schulte, Ph.D, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295719
- Sponsor's protocol ID
- 2019-07195
- Other IDs
- GRANT12908084, 2019
- Acronym
- HIIT&PUFA
- Status last verified
- Sep 2025
- First submitted
- 14 Dec 2021
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Fish Oil and Exercise to Improve Obesity-associated Inflammation
- ClinicalTrials.gov ID
- NCT05295719
- Acronym / sponsor ID
- HIIT&PUFA / 2019-07195
- Conditions
- Obesity, Inflammation, Human Microbiome, Insulin Resistance, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- University of Houston, Texas Tech University Health Sciences Center
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.
Detailed description
Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative to understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk. These studies will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia.
The first aim of this study will focus on determining the combined effects of n-3 PUFA and HIIT on improving metabolic risks such as obesity-related markers of inflammation, dyslipidemia, and insulin resistance.
The investigators will test the hypothesis that n-3 PUFA, in addition to HIIT, will have beneficial effects on energy utilization, as well as obesity-related markers of inflammation, dyslipidemia and insulin resistance.
Aim 2.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition Aim 2.2: Investigate the influence of n-3 PUFA and HIIT on serum markers associated with obesity Aim 2.3: Investigate influence of n-3 PUFA and HIIT on energy utilization/ markers of insulin resistance
The second aim is to determine the combined effects of n-3 polyunsaturated fatty acids (n-3 PUFA) and high-intensity interval training (HIIT) on improving gut dysbiosis.
The investigators will test the hypothesis that n-3 PUFA supplementation will improve gut microbiota composition and related metabolites, which will result in reduced inflammation and ameliorate the metabolic response to a HIIT exercise intervention in an overweight population.
Aim 1.1: Investigate the influence of n-3 PUFA and exercise on gut microbiota composition
Aim 1.2: Investigate the influence of n-3 PUFA and exercise on microbiota produced metabolites
Participants will be randomly allocated to 1 of 4 treatment groups (n = 120), each balanced for sex, BMI, lipid profile, and dietary intake. The goal is to conduct the study in smaller cohorts, such as 10-15 participants/group (n = 40-60).
Participants will first be allocated to two groups: One group will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) and one group will take placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) for 4 weeks of initial supplementation.
Following this, one group from the treatment and one from the placebo group (creating 4 groups: (1) placebo + low-intensity training (LIT); (2) n-3 PUFA + LIT; (3) placebo + HIIT; (4) n-3 PUFA + HIIT) will also participate in a 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program utilizing cycle ergometers on 3 days/week conducted in the research lab and under investigator supervision for 4 weeks while continuing supplementation.
If not asked to exercise, participants will be instructed to maintain their normal level of physical activity but will participate in a time-matched session of low-intensity training (50% HRmax) on 3 days/week conducted in the research lab and under investigator supervision.
All participants will wear a heart rate monitor (Polar H10) provided by TTU throughout the training (HIIT and LIT) to monitor exertion level.
Capsules will be administered in a double-blind fashion and will be identical in appearance. Participants will visit the clinic to pick up capsules. To ensure compliance, subjects will be reminded via phone (text message or phone call based on participant preference) to take their capsules and counts will be conducted when they come in for study visits.
As with any acute metabolic or physiological improvements, beneficial effects of exercise on bacterial taxa and resultant metabolite production are quickly reversed with detraining. Thus, it is of interest to determine if fish consumption can ameliorate the negative metabolic and gut effects of detraining.
At the end of the 4-week intervention (week 8), participants will cease engaging in HIIT or LIT for a 2-week detraining period. Participants will continue taking their assigned supplements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo & Flexibility Training (Control) | Placebo comparator | Dietary Supplement: Safflower oil, Behavioral: Low-intensity trainingSubjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in low-intensity training (control group) for 30 minutes 3 times/week for 4 weeks. All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and will cease low-intensity training for a 2 week follow-up period. |
| Placebo & High-Intensity Interval Training | Active comparator | Behavioral: High-Intensity Interval Training, Dietary Supplement: Safflower oilSubjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease HIIT training for a 2 week follow-up period. |
| n-3 PUFA & Flexibility Training (Control) | Active comparator | Dietary Supplement: Omega-3 polyunsaturated fatty acid, Behavioral: Low-intensity trainingSubjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in low-intensity training (control group) for 30 minutes 3 times/week for 4 weeks. All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease low-intensity training for a 2 week follow-up period. |
| n-3 PUFA & High-Intensity Interval Training | Experimental | Dietary Supplement: Omega-3 polyunsaturated fatty acid, Behavioral: High-Intensity Interval TrainingSubjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease low-intensity training for a 2 week follow-up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old
- Overweight/ Obese (BMI ≥ 25 to ≤ 40 kg/m2)
- Elevated Triglycerides (>150 mg/dL)
- Prediabetes (fasting blood glucose 100 to 125 mg/dl)
Key exclusion criteria (10 listed)
- Diagnosed with Diabetes or liver disease.
- Taking BP or diabetes medications.
- Received antibiotics medications in the last 6 months.
- Pregnant/ lactating/ Irregular menstrual cycle/ menopausal.
- Currently following a formal/ structured weight loss program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 polyunsaturated fatty acidAlso: AlaskOmega4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) | Dietary supplement | n-3 PUFA & Flexibility Training (Control), n-3 PUFA & High-Intensity Interval Training |
| High-Intensity Interval TrainingAlso: HIITA 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max. | Behavioural | Placebo & High-Intensity Interval Training, n-3 PUFA & High-Intensity Interval Training |
| Safflower oilAlso: Placebo4 grams safflower oil (AlaskOmega®) per day | Dietary supplement | Placebo & Flexibility Training (Control), Placebo & High-Intensity Interval Training |
| Low-intensity trainingA low-intensity training exercise program 3 days/week for 4 weeks. This will include consistently cycling at 50% HRmax for 30 min. | Behavioural | Placebo & Flexibility Training (Control), n-3 PUFA & Flexibility Training (Control) |
Primary outcome
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 4 weeks
Time frame: Post-Supplementation at week 4
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Interleukin (IL)-6 at 4 weeks
Time frame: Post-Supplementation at week 4
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 4 weeks
Time frame: Post-Supplementation at week 4
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 4 weeks
Time frame: Post-Supplementation at week 4
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Tumor necrosis factor at 4 weeks
Time frame: Post-Supplementation at week 4
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Total Cholesterol at 4 weeks
Time frame: Post-Supplementation at week 4
Total cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL)at 4 weeks
Time frame: Post-Supplementation at week 4
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 4 weeks
Time frame: Post-Supplementation at week 4
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 4 weeks
Time frame: Post-Supplementation at week 4
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 4 weeks
Time frame: Post-Supplementation at week 4
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Triglycerides at 4 weeks
Time frame: Post-Supplementation at week 4
Triglycerides (mg/dL).
Mean Change from Baseline in Total/HDL cholesterol at 4 weeks
Time frame: Post-Supplementation at week 4
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Fasting blood glucose at 4 weeks
Time frame: Post-supplementation at week 4
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Insulin at 4 weeks
Time frame: Post-supplementation at week 4
Insulin (μU/mL)
Mean Change from Baseline in Total Body Fat Percentage at 4 weeks
Time frame: Post-Supplementation at week 4
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Baseline in Body Weight at 4 weeks
Time frame: Post-Supplementation at week 4
Body weight (kilograms)
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 4 weeks
Time frame: Post-Supplementation at week 4
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks
Time frame: Post-Intervention at week 8
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks
Time frame: Post-Intervention at week 8
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks
Time frame: Post-Intervention at week 8
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks
Time frame: Post-Intervention at week 8
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Tumor necrosis factor (TNF) at 8 weeks
Time frame: Post-Intervention at week 8
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Total Cholesterol at 8 weeks
Time frame: Post-Intervention at week 8
Total Cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 8 weeks
Time frame: Post-Intervention at week 8
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Time frame: Post-intervention at week 8
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks
Time frame: Post-Intervention at week 8
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks
Time frame: Post-Intervention at week 8
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Triglycerides at 8 weeks
Time frame: Post-Intervention at week 8
Triglycerides (mg/dL).
Mean Change from Baseline in total/HDL cholesterol at 8 weeks
Time frame: Post-Intervention at week 8
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Fasting blood glucose at 8 weeks
Time frame: Post-Intervention at week 8
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks
Time frame: Post-Intervention at week 8
Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.
Mean Change from Baseline in Insulin at 8 weeks
Time frame: Post-Intervention at week 8
Insulin (μU/mL)
Mean Change from Baseline in Body Weight at 8 weeks
Time frame: Post-Intervention at week 8
Body weight (kilograms)
Mean Change from Baseline in Total Body Fat Percentage at 8 weeks
Time frame: Post-Intervention at week 8
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks
Time frame: Post-Intervention at week 8
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 10 weeks
Time frame: Post-Detraining at week 10
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Interleukin (IL)-6 at 10 weeks
Time frame: Post-Detraining at week 10
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 10 weeks
Time frame: Post-Detraining at week 10
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Tumor necrosis factor (TNF) at 10 weeks
Time frame: Post-Detraining at week 10
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 10 weeks
Time frame: Post-Detraining at week 10
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Total Cholesterol at 10 weeks
Time frame: Post-Detraining at week 10
Total Cholesterol (mg/dL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 10 weeks
Time frame: Post-Detraining at week 10
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Time frame: Post-Detraining at week 10
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 10 weeks
Time frame: Post-Detraining at week 10
Low-density lipoprotein (LDL)(mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 10 weeks
Time frame: Post-Detraining at week 10
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Total/HDL cholesterol at 10 weeks
Time frame: Post-Detraining at week 10
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Triglycerides at 10 weeks
Time frame: Post-Detraining at week 10
Triglycerides (mg/dL)
Mean Change from Baseline in Insulin at 10 weeks
Time frame: Post-Detraining at week 10
Insulin (μU/mL)
Mean Change from Baseline in Fasting blood glucose at 10 weeks
Time frame: Post-Detraining at week 10
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 10 weeks
Time frame: Post-Detraining at week 10
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
Mean Change from Baseline in Body weight at 10 weeks
Time frame: Post-Detraining at week 10
Body weight (kilograms)
Mean Change from Baseline in Total Body Fat Percentage at 10 weeks
Time frame: Post-Detraining at week 10
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 8 weeks
Time frame: Post-Intervention at week 8
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Post-Supplementation in Interleukin (IL)-6 at 8 weeks
Time frame: Post-Intervention at week 8
Interleukin (IL)-6 (pg/mL)
Mean Change from Post-Supplementation in Interleukin (IL)-10 at 8 weeks
Time frame: Post-Intervention at week 8
Interleukin (IL)-10 (pg/mL)
Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 8 weeks
Time frame: Post-Intervention at week 8
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 8 weeks
Time frame: Post-Intervention at week 8
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Post-Supplementation in Total Cholesterol at 8 weeks
Time frame: Post-Intervention at week 8
Total Cholesterol (mg/dL)
Mean Change from Post-Supplementation in Total/HDL cholesterol at 8 weeks
Time frame: Post-Intervention at week 8
Total/HDL cholesterol (mg/dL)
Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 8 weeks
Time frame: Post-Intervention at week 8
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 8 weeks
Time frame: Post-Intervention at week 8
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 8 weeks
Time frame: Post-Intervention at week 8
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 8 weeks
Time frame: Post-Intervention at week 8
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Post-Supplementation in Triglycerides at 8 weeks
Time frame: Post-Intervention at week 8
Triglycerides (mg/dL)
Mean Change from Post-Supplementation in Insulin at 8 weeks
Time frame: Post-Intervention at week 8
Insulin (μU/mL)
Mean Change from Post-Supplementation in Fasting blood glucose at 8 weeks
Time frame: Post-Intervention at week 8
Fasting blood glucose (mg/dL)
Mean Change from Post-Supplementation in Body weight at 8 weeks
Time frame: Post-Intervention at week 8
Body weight (kilograms)
Mean Change from Post-Supplementation in Total Body Fat Percentage at 8 weeks
Time frame: Post-Intervention at week 8
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 10 weeks
Time frame: Post-Detraining at week 10
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 10 weeks
Time frame: Post-Detraining at week 10
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Post-Intervention in Interleukin (IL)-6 at 10 weeks
Time frame: Post-Detraining at week 10
Interleukin (IL)-6 (pg/mL)
Mean Change from Post-Intervention in Interleukin (IL)-10 at 10 weeks
Time frame: Post-Detraining at week 10
Interleukin (IL)-10 (pg/mL)
Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 10 weeks
Time frame: Post-Detraining at week 10
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Post-Intervention in Total Cholesterol at 10 weeks
Time frame: Post-Detraining at week 10
Total Cholesterol (mg/dL)
Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 10 weeks
Time frame: Post-Detraining at week 10
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 10 weeks
Time frame: Post-Detraining at week 10
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 10 weeks
Time frame: Post-Detraining at week 10
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 10 weeks
Time frame: Post-Detraining at week 10
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Post-Intervention in Total/HDL cholesterol at 10 weeks
Time frame: Post-Detraining at week 10
Total/HDL cholesterol (mg/dL)
Mean Change from Post-Intervention in Triglycerides at 10 weeks
Time frame: Post-Detraining at week 10
Triglycerides (mg/dL)
Mean Change from Post-Intervention in Insulin at 10 weeks
Time frame: Post-Detraining at week 10
Insulin (μU/mL)
Mean Change from Post-Intervention in Fasting blood glucose at 10 weeks
Time frame: Post-Detraining at week 10
Fasting blood glucose (mg/dL)
Mean Change from Post-Intervention in Body weight at 10 weeks
Time frame: Post-Detraining at week 10
Body weight (kilograms)
Mean Change from Post-Intervention in Total Body Fat Percentage at 10 weeks
Time frame: Post-Detraining at week 10
Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.
Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 10 weeks
Time frame: Post-Detraining at week 10
Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.
35 secondary outcomes
Mean Change from Baseline in Bacterial Profile at 4 weeks
Time frame: Post-Supplementation at week 4
Mean Change from Baseline in Serum Acetate Profile at 4 weeks
Time frame: Post-Supplementation at week 4
Mean Change from Baseline in Fecal acetate Profile at 4 weeks
Time frame: Post-Supplementation at week 4
Mean Change from Baseline in Propionate Profile at 4 weeks
Time frame: Post-Supplementation at week 4
Mean Change from Baseline in Butyrate Profile at 4 weeks
Time frame: Post-Supplementation at week 4
Mean Change from Baseline in Markers of Serum lipopolysaccharides at 4 weeks
Time frame: Post-Supplementation at week 4
Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 4 weeks
Time frame: Post-Supplementation at week 4
Mean Change from Baseline in Bacterial Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Baseline in Serum Acetate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Baseline in Fecal acetate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Baseline in Propionate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Baseline in Butyrate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Baseline in Serum Acetate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Baseline in Fecal acetate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Baseline in Bacterial Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Baseline in Propionate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Baseline in Butyrate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Baseline in Markers of Serum lipopolysaccharides at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Post-Supplementation in Bacterial Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Post-Supplementation in Serum Acetate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Post-Supplementation in Fecal acetate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Post-Supplementation in Propionate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Post-Supplementation in Butyrate Profile at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 8 weeks
Time frame: Post-Intervention at week 8
Mean Change from Post-Intervention in Bacterial Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Post-Intervention in Serum Acetate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Post-Intervention in Fecal acetate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Post-Intervention in Propionate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Post-Intervention in Butyrate Profile at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 10 weeks
Time frame: Post-Detraining at week 10
Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 10 weeks
Time frame: Post-Detraining at week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kembra D Albracht-Schulte, Ph.D principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 polyunsaturated fatty acid, High-Intensity Interval Training and Safflower oil in people with Obesity and Inflammation, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 4 weeks (time frame: Post-Supplementation at week 4). The study lists 85 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.