Overweight and ObesityPHAEOSOL-ONENCT04761406
Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management
A study testing Phaeosol group in people with Overweight and Obesity and Body Weight Changes, run by Microphyt at 1 site in United States.
Trial summary
PhaoeSOL (Microphyt, Baillargues, France) is a microalgae-based nutritional ingredient developed with a patented production process that has New Dietary Ingredient (NDI) status from the FDA (#1120). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Body Weight Changes, Healthy Lifestyle
- What is being tested?
- Phaeosol group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 1 Nov 2023
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has given voluntary, written, informed consent to participate in the study;
- Healthy pre-menopausal females age 18 - 50 years;
- Body mass index (BMI) between 25 - 35 kg/m2 and/or body fat >30%; preferred BMI between 25-32 kg/m2; mean BMI in each group has to be in the range of 25-29.9.
- Free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance);
- In generally good health; and,
- Willing to maintain consistent sleep duration the evening before study visits.
- Mean average BMI will be controlled during phone screening. Anyone with a BMI from 25-29.9 (assuming other inclusion criteria are met with no exclusion criteria) will be enrolled and a list of alternatives for borderline subjects will be kept (e.g. up to 32). A log of active participants will be kept so subjects above 30 will not be added unless the mean is within 25-29.9 range
Who cannot join
- Are pregnant, breastfeeding, or wish to become pregnant during the study;
- Plan major changes in lifestyle (i.e. diet, dieting, exercise level, travel) during the study;
- Have a recent history (<3 months) of exercise training or weight loss (> 5%);
- Have an orthopedic limitation that would prevent participation in a general fitness program;
- Have uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder;
- Have taken weight loss dietary supplements or medications during the last 4-wks;
Show all 11Show fewer
- Have a history of chronic use of oral or injectable corticosteroids;
- Have a history within previous 12 months of alcohol or substance abuse;
- Are a heavy smoking (>1 pack/day within past 3 months);
- Have a history of heavy caffeinated beverage consumption (>400mg caffeine/day) within past 2 weeks; or,
- Have known allergy to any of the ingredients in the supplement product or placebo.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Lab
College Station, Texas, 77843-4253
About this study
Official title: Efficacy of a Microalgae Extract PhaeoSOL on Optimizing the Benefits of Healthy, Overweight and Moderately Obese Women Participating in an Exercise and Weight Management Program.
PhaoeSOL (Microphyt, Baillargues, France) is a microalgae-based nutritional ingredient developed with a patented production process that has New Dietary Ingredient (NDI) status from the FDA (#1120). It is an extract of the microalgae Phaeodactylum tricornutum standardized to 2.0% Fucoxanthin (FX) content by adding a food grade medium-chain triglyceride (MCT)-oil and a tocopherol-rich (Vitamin E) extract (0.5 % w:w). PhaeoSOL is intended for use as a source of the naturally occurring carotenoid, fucoxanthin, in food supplement products for the general population at levels not to exceed 437 mg/person/day for a maximal duration of 30 days of PhaeoSOL (equivalent to 10 mg fucoxanthin/person/day). Prior studies suggest that marine algae and Fucoxanthinol may have anti-obesity, lipid lowering, and glucose management enhancing properties. The purpose of this proof of concept pilot study is to examine whether dietary supplementation of PhaoeSOL enhances the benefits of women participating in an exercise and weight management program.
Read the detailed description
All participants will participate in a supervised exercise training 3 days per week at the HCRF consisting of a 5-min warm-up, light stretching, resistance training (3 sets of 10 repetitions @ 60%-80% 1RM on the bench press, seated row, shoulder press, lat pulldown, biceps curl, triceps extension, leg press, leg extension, leg curl, abdominal crunch/curl, back extension), and cardiovascular training (walking or cycling for 20 to 30 min training at 60% to 80% heart rate reserve [HRR]). Additionally, participants will be asked to accumulate 10,000 steps per day of brisk walking on non-training days (goal > 100 min./wk. of moderate to vigorous exercise). Training will be recorded on training logs and by using an iPhone, Fitbit or pedometer.
Participants will be given 1,400, 1,500 kcal/day or 1,600 kcal/day diets based on resting energy expenditure determination designed to promote a 400-500 kcal/d energy intake deficit following the American Heart Association (AHA) macronutrient distribution recommendations (55% CHO, 30% FAT, 15% PRO). A goal energy intake, weekly diet plan, examples, and a food substitution list will be provided. A phone app (e.g., MyFoodDiary) will be used to help participants monitor and adhere to energy intake goals. In our prior studies, this exercise and diet intervention has been shown to promote a 3-5 kg fat loss, 3-5% decrease in percent body fat, a maintenance in fat free mass and REE, and improved health outcomes.
Primary Endpoints: Differences in body weight, body fat mass (kg and %), and waist and hip circumference at weeks 6 and 12 compared to baseline.
Secondary Endpoints: Differences in resting energy expenditure, aerobic capacity, estimated 1RM, muscular endurance total work, training volume, energy and macronutrient intake, blood lipids, and HbA1c, IL6, CRPhs, TNFa, INF, Leptin, HbA1C, Insulin, Glucose, Comprehensive Clinical Panel (HDL, LDL, TG, BUN, CREAT, etc.), side effects, SF-36 quality of life at weeks 6 and 12 compared to baseline.
- Conditions
- Overweight and Obesity, Body Weight Changes, Healthy Lifestyle, Exercise, Dietary Supplement
- Being tested
- Phaeosol group, Placebo group
- Keywords
- Fucoxanthin, Weight management, Microalgae, Exercise, Overweight
- Medical subject headings
- Overweight, Obesity, Body Weight Changes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phaeosol groupDietary supplement
In a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks:
Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d)
Supplements will be prepared in softgel capsules for double blind administration by the sponsor.
Placebo groupDietary supplement
In a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks:
Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d)
Supplements will be prepared in softgel capsules for double blind administration by the sponsor.
| Study group | Role | What they receive |
|---|---|---|
| Phaeosol group | Experimental | Daily supplementation of Phaeosol softgel capsule (218mg/d), active ingredients of Microphyt. Each randomized subject will consume 1 softgel capsule (before breakfast) per day during 12 weeks Receives: Dietary Supplement: Phaeosol group |
| Placebo group | Placebo comparator | Daily supplementation of placebo softgel capsule (218mg/d of 100% sunflower oil) with the same appearance and packaging than experimental product. Each randomized subject will consume 1 softgel capsule (before breakfast) per day during 12 weeks Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat mass (in Kg)
Difference in body fat mass (kg) evaluated by DEXA between weeks 6 and 12 compared to baseline.
Measured: 6 and 12 weeks
Body fat mass (in % of total body weight)
Difference in body fat mass (% of total body weight) evaluated by DEXA between weeks 6 and 12 compared to baseline
Measured: 6 and 12 weeks
Secondary outcomes (28)
Total body weight (Kg)
Difference in total body weight between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Waist circumference (cm)
Difference in waist circumference between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Hip circumference (cm)
Difference in hip circumference between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Resting energy expenditure (Kcal/day)
Difference in resting energy expenditure between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Maximum oxygen uptake (ml/kg/min)
Difference in aerobic capacity between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Muscle strenght - 1 Repetition Maximum (Kg)
Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Muscle strenght - 1 Repetition Maximum (% of estimated)
Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Muscular endurance total work (Kg)
Difference in muscular endurance total work between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Energy daily intake (Kcal/day)
Difference in energy and macronutrient intake between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood HDL-cholesterol level (g/l)
Difference in blood HDL-cholesterol level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood LDL-cholesterol level (g/l)
Difference in blood LDL-cholesterol level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood total cholesterol level (g/l)
Difference in blood total cholesterol level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood TGL level (g/l)
Difference in blood TGL level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
blood TNFa level (pg/ml)
Difference in blood TNFa level weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
blood INF level (pg/ml)
Difference in blood INF level weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
blood IL6 level (pg/ml)
Difference in blood IL6 level weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
blood CRPhs level (pg/ml)
Difference in blood CRPhs level weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood insulin level (mUI/l)
Difference in blood insulin level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood glucose level (mmol/l)
Difference in blood glucose level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood leptin level (ng/ml)
Difference in blood leptin level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood HbA1C level (%)
Difference in blood HbA1C level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood Creatinine level (umol/l)
Difference in blood Creatinine level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood total protein level (mmol/l)
Difference in blood total protein level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood Urea/BUN ratio (mmol/l)
Difference in blood Urea/BUN ratio between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood Uric acid level (umol/l)
Difference in blood uric acid level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood AST level (U/l)
Difference in blood AST level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Blood ALT level (U/l)
Difference in blood ALT level between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Quality of life score (SF-36)
Difference in quality of life score between weeks 6 and 12 weeks compared to baseline
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start26 Apr 2021
- Primary completion1 May 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo controlled, double-blind, parallel arm intervention trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microphyt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Richard B. Kreider, Principal investigator, Exercise & Sport Nutrition Lab, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761406
- Sponsor's protocol ID
- IRB2020-1443
- Acronym
- PHAEOSOL-ONE
- Status last verified
- Nov 2023
- First submitted
- 8 Feb 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dickerson B, Maury J, Jenkins V, Nottingham K, Xing D, Gonzalez DE, Leonard M, Kendra J, Ko J, Yoo C, Johnson S, Pradelles R, Purpura M, Jager R, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Supplementation with Microalgae Extract from Phaeodactylum tricornutum (Mi136) to Support Benefits from a Weight Management Intervention in Overweight Women. Nutrients. 2024 Mar 28;16(7):990. doi: 10.3390/nu16070990.
PubMed 38613023Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15.
PubMed 33993853
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Microalgae Extract PhaeoSOL on Optimizing the Benefits of Healthy, Overweight and Moderately Obese Women Participating in an Exercise and Weight Management Program.
- ClinicalTrials.gov ID
- NCT04761406
- Acronym / sponsor ID
- PHAEOSOL-ONE / IRB2020-1443
- Conditions
- Overweight and Obesity, Body Weight Changes, Healthy Lifestyle, Exercise, Dietary Supplement
- Keywords
- Fucoxanthin, Weight management, Microalgae, Exercise, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- MicrophytIndustry (pharma, biotech, devices)
- Collaborators
- Texas A&M University
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Feb 2021 (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.
PhaoeSOL (Microphyt, Baillargues, France) is a microalgae-based nutritional ingredient developed with a patented production process that has New Dietary Ingredient (NDI) status from the FDA (#1120). It is an extract of the microalgae Phaeodactylum tricornutum standardized to 2.0% Fucoxanthin (FX) content by adding a food grade medium-chain triglyceride (MCT)-oil and a tocopherol-rich (Vitamin E) extract (0.5 % w:w). PhaeoSOL is intended for use as a source of the naturally occurring carotenoid, fucoxanthin, in food supplement products for the general population at levels not to exceed 437 mg/person/day for a maximal duration of 30 days of PhaeoSOL (equivalent to 10 mg fucoxanthin/person/day). Prior studies suggest that marine algae and Fucoxanthinol may have anti-obesity, lipid lowering, and glucose management enhancing properties. The purpose of this proof of concept pilot study is to examine whether dietary supplementation of PhaoeSOL enhances the benefits of women participating in an exercise and weight management program.
Detailed description
All participants will participate in a supervised exercise training 3 days per week at the HCRF consisting of a 5-min warm-up, light stretching, resistance training (3 sets of 10 repetitions @ 60%-80% 1RM on the bench press, seated row, shoulder press, lat pulldown, biceps curl, triceps extension, leg press, leg extension, leg curl, abdominal crunch/curl, back extension), and cardiovascular training (walking or cycling for 20 to 30 min training at 60% to 80% heart rate reserve [HRR]). Additionally, participants will be asked to accumulate 10,000 steps per day of brisk walking on non-training days (goal > 100 min./wk. of moderate to vigorous exercise). Training will be recorded on training logs and by using an iPhone, Fitbit or pedometer.
Participants will be given 1,400, 1,500 kcal/day or 1,600 kcal/day diets based on resting energy expenditure determination designed to promote a 400-500 kcal/d energy intake deficit following the American Heart Association (AHA) macronutrient distribution recommendations (55% CHO, 30% FAT, 15% PRO). A goal energy intake, weekly diet plan, examples, and a food substitution list will be provided. A phone app (e.g., MyFoodDiary) will be used to help participants monitor and adhere to energy intake goals. In our prior studies, this exercise and diet intervention has been shown to promote a 3-5 kg fat loss, 3-5% decrease in percent body fat, a maintenance in fat free mass and REE, and improved health outcomes.
Primary Endpoints: Differences in body weight, body fat mass (kg and %), and waist and hip circumference at weeks 6 and 12 compared to baseline.
Secondary Endpoints: Differences in resting energy expenditure, aerobic capacity, estimated 1RM, muscular endurance total work, training volume, energy and macronutrient intake, blood lipids, and HbA1c, IL6, CRPhs, TNFa, INF, Leptin, HbA1C, Insulin, Glucose, Comprehensive Clinical Panel (HDL, LDL, TG, BUN, CREAT, etc.), side effects, SF-36 quality of life at weeks 6 and 12 compared to baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo controlled, double-blind, parallel arm intervention trial.
| Arm | Type | Receives |
|---|---|---|
| Phaeosol group | Experimental | Dietary Supplement: Phaeosol groupDaily supplementation of Phaeosol softgel capsule (218mg/d), active ingredients of Microphyt. Each randomized subject will consume 1 softgel capsule (before breakfast) per day during 12 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupDaily supplementation of placebo softgel capsule (218mg/d of 100% sunflower oil) with the same appearance and packaging than experimental product. Each randomized subject will consume 1 softgel capsule (before breakfast) per day during 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Has given voluntary, written, informed consent to participate in the study;
- Healthy pre-menopausal females age 18 - 50 years;
- Body mass index (BMI) between 25 - 35 kg/m2 and/or body fat >30%; preferred BMI between 25-32 kg/m2; mean BMI in each group has to be in the range of 25-29.9.
- Free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance);
- In generally good health; and,
Key exclusion criteria (11 listed)
- Are pregnant, breastfeeding, or wish to become pregnant during the study;
- Plan major changes in lifestyle (i.e. diet, dieting, exercise level, travel) during the study;
- Have a recent history (<3 months) of exercise training or weight loss (> 5%);
- Have an orthopedic limitation that would prevent participation in a general fitness program;
- Have uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder;
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 |
|---|---|---|
| Phaeosol groupIn a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks: Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d) Supplements will be prepared in softgel capsules for double blind administration by the sponsor. | Dietary supplement | Phaeosol group |
| Placebo groupIn a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks: Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d) Supplements will be prepared in softgel capsules for double blind administration by the sponsor. | Dietary supplement | Placebo group |
Primary outcome
Body fat mass (in Kg)
Time frame: 6 and 12 weeks
Difference in body fat mass (kg) evaluated by DEXA between weeks 6 and 12 compared to baseline.
Body fat mass (in % of total body weight)
Time frame: 6 and 12 weeks
Difference in body fat mass (% of total body weight) evaluated by DEXA between weeks 6 and 12 compared to baseline
28 secondary outcomes
Total body weight (Kg)
Time frame: 6 and 12 weeks
Waist circumference (cm)
Time frame: 6 and 12 weeks
Hip circumference (cm)
Time frame: 6 and 12 weeks
Resting energy expenditure (Kcal/day)
Time frame: 6 and 12 weeks
Maximum oxygen uptake (ml/kg/min)
Time frame: 6 and 12 weeks
Muscle strenght - 1 Repetition Maximum (Kg)
Time frame: 6 and 12 weeks
Muscle strenght - 1 Repetition Maximum (% of estimated)
Time frame: 6 and 12 weeks
Muscular endurance total work (Kg)
Time frame: 6 and 12 weeks
Energy daily intake (Kcal/day)
Time frame: 6 and 12 weeks
Blood HDL-cholesterol level (g/l)
Time frame: 6 and 12 weeks
Blood LDL-cholesterol level (g/l)
Time frame: 6 and 12 weeks
Blood total cholesterol level (g/l)
Time frame: 6 and 12 weeks
Blood TGL level (g/l)
Time frame: 6 and 12 weeks
blood TNFa level (pg/ml)
Time frame: 6 and 12 weeks
blood INF level (pg/ml)
Time frame: 6 and 12 weeks
blood IL6 level (pg/ml)
Time frame: 6 and 12 weeks
blood CRPhs level (pg/ml)
Time frame: 6 and 12 weeks
Blood insulin level (mUI/l)
Time frame: 6 and 12 weeks
Blood glucose level (mmol/l)
Time frame: 6 and 12 weeks
Blood leptin level (ng/ml)
Time frame: 6 and 12 weeks
Blood HbA1C level (%)
Time frame: 6 and 12 weeks
Blood Creatinine level (umol/l)
Time frame: 6 and 12 weeks
Blood total protein level (mmol/l)
Time frame: 6 and 12 weeks
Blood Urea/BUN ratio (mmol/l)
Time frame: 6 and 12 weeks
Blood Uric acid level (umol/l)
Time frame: 6 and 12 weeks
Blood AST level (U/l)
Time frame: 6 and 12 weeks
Blood ALT level (U/l)
Time frame: 6 and 12 weeks
Quality of life score (SF-36)
Time frame: 6 and 12 weeks
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 8 Nov 2023.
- Derived from this study: PubMed 38613023Dickerson B, Maury J, Jenkins V, Nottingham K, Xing D, Gonzalez DE, Leonard M, Kendra J, Ko J, Yoo C, Johnson S, Pradelles R, Purpura M, Jager R, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Supplementation with Microalgae Extract from Phaeodactylum tricornutum (Mi136) to Support Benefits from a Weight Management Intervention in Overweight Women. Nutrients. 2024 Mar 28;16(7):990. doi: 10.3390/nu16070990.
- Derived from this study: PubMed 33993853Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15.
- 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.
Richard B. Kreider principal investigator
Exercise & Sport Nutrition Lab, Texas A&M 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 Phaeosol group in people with Overweight and Obesity and Body Weight Changes, run by Microphyt 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 7 inclusion and 11 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 8 Nov 2023. 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?
Body fat mass (in Kg) (time frame: 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761406, which also lists 2 linked publications.
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 8 Nov 2023.