Time Restricted EatingNCT06302231
Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity
A study testing Dietary and Exercise Approaches and Dietary Approach in people with Time Restricted Eating and Obesity, run by Federal University of Rio Grande do Sul.
Trial summary
Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Eating, Obesity, Intermittent Fasting
- What is being tested?
- Dietary and Exercise Approaches and Dietary Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female;
- Body mass index (BMI) between 25 and 34.9 kg/m²;
- Age between 20 and 40 years;
- Not engaged in any structured exercise program;
- Weight stable for ~3 months before the beginning of the study;
- Able to give written informed consent.
Who cannot join
- Current smoker;
- Habitual drinkers (>1 serving/day) of alcoholic beverages;
- Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
- Current treatment with medication or supplements which significantly affect the main studied variables;
- Bariatric surgery;
- Night-shift workers;
Show all 12Show fewer
- Strict vegetarian/vegan;
- Pregnancy, planned pregnancy (within the study period), lactating;
- Postmenopausal women;
- Self-reported menstrual cycle irregularities;
- Habitual fasting window >16 hours;
- Concomitant participation in other studies.
About this study
Official title: Effects of Time-restricted Eating Combined With Aerobic Exercise Training on Body Composition and Cardiometabolic Parameters in Women With Overweight and Obesity: a Randomized Clinical Trial
Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.
Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.
The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity.
- Conditions
- Time Restricted Eating, Obesity, Intermittent Fasting, Overweight and Obesity, Time Restricted Feeding
- Being tested
- Dietary and Exercise Approaches, Dietary Approach
- Medical subject headings
- Intermittent Fasting, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and Exercise ApproachesBehavioural
Intermittent fasting plus energy restriction combined with aerobic exercise performed in a fasted state.
Dietary and Exercise ApproachesBehavioural
Intermittent fasting plus energy restriction combined with aerobic exercise performed in a fed state.
Dietary ApproachBehavioural
Intermittent fasting plus energy restriction without aerobic exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating and Aerobic Exercise Performed in Fasted State | Experimental | Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them.
Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat.
Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner).
Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the morning shift with participants in a fasted state. Receives: Behavioral: Dietary and Exercise Approaches |
| Time-Restricted Eating and Aerobic Exercise Performed in Fed State | Active comparator | Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them.
Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat.
Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner).
Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the afternoon shift with participants in a fed state. Receives: Behavioral: Dietary and Exercise Approaches |
| Time-Restricted Eating | Other | Participants will be prescribed a diet plan to promote weight loss, but no food will be provided to them.
Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat.
Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner).
Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Participants in this arm will not perform aerobic exercise training. Receives: Behavioral: Dietary Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity (indices)
Including but not limited to the Sensitivity Matsuda index
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Secondary outcomes (23)
Insulin resistance (indices)
Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting insulin levels (µIU/mL)
Measured by enzyme-Linked Immunosorbent Assay
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting glucose levels (mg/dL)
Measured by colorimetric method
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Glucose tolerance
Measured by oral glucose tolerance test (2-h OGTT)
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting lipid profile levels
Measured by colorimetric method
Measured: Change from baseline. Measured at baseline and after 8 weeks.
β cell function (indices)
Including but not limited to HOMA-β
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fat Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fat Percentage (%)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fat Free Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Measured on a digital scale.
Measured: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Bone Mineral Content (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Body Mass Index (kg/m^2)
Calculated from weight in kilograms divided by height in meters squared.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Resting metabolic rate (Kcal/day)
Measured by indirect calorimetry under resting and fasting conditions.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Substrate Oxidation (respiratory exchange ratio)
Measured by indirect calorimetry under resting and fasting conditions.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Absolute Peak oxygen consumption
Measured by an open-circuit spirometry system. Absolute value expressed in litres of oxygen per minute (L/min).
Measured: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Relative Peak oxygen consumption
Measured by an open-circuit spirometry system. Relative to body weight and expressed in milliliters of oxygen per minute (mL/kg/min).
Measured: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Fasting Leptin Levels
Measured by enzyme-Linked Immunosorbent Assay
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Fasting Adiponectin Levels
Measured by enzyme-Linked Immunosorbent Assay
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Inflammatory Markers Levels
Including but not limited to TNF-α (tumor necrosis factor-alpha) and IL-10 (Interleukin-10); Measured by enzyme-Linked Immunosorbent Assay
Measured: Change from baseline. Measured at baseline and after 8 weeks.
LDL-cholesterol levels
Measured using the Friedewald equation.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Non-HDL-cholesterol levels
Calculated as total cholesterol minus HDL-cholesterol.
Measured: Change from baseline. Measured at baseline and after 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Restricted EatingStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302231
- Sponsor's protocol ID
- 16690919.5.0000.5347
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-restricted Eating Combined With Aerobic Exercise Training on Body Composition and Cardiometabolic Parameters in Women With Overweight and Obesity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06302231
- Acronym / sponsor ID
- 16690919.5.0000.5347
- Conditions
- Time Restricted Eating, Obesity, Intermittent Fasting, Overweight and Obesity, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Mar 2024 (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.
Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated.
Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity.
The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating and Aerobic Exercise Performed in Fasted State | Experimental | Behavioral: Dietary and Exercise ApproachesParticipants will be prescribed a diet plan to promote weight loss, but no food will be provided to them. Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat. Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner). Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the morning shift with participants in a fasted state. |
| Time-Restricted Eating and Aerobic Exercise Performed in Fed State | Active comparator | Behavioral: Dietary and Exercise ApproachesParticipants will be prescribed a diet plan to promote weight loss, but no food will be provided to them. Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat. Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner). Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Aerobic exercise sessions will be carried out during the afternoon shift with participants in a fed state. |
| Time-Restricted Eating | Other | Behavioral: Dietary ApproachParticipants will be prescribed a diet plan to promote weight loss, but no food will be provided to them. Diets will be formulated to contain 50% energy as carbohydrate, 20% as protein, and 30 % as fat. Participants will be instructed to divide their daily energy intake between three meals each day (lunch, afternoon snack, and dinner). Participants will be instructed to eat from 12.00 until 20.00 (8-hour window). Participants in this arm will not perform aerobic exercise training. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female;
- Body mass index (BMI) between 25 and 34.9 kg/m²;
- Age between 20 and 40 years;
- Not engaged in any structured exercise program;
- Weight stable for ~3 months before the beginning of the study;
Key exclusion criteria (12 listed)
- Current smoker;
- Habitual drinkers (>1 serving/day) of alcoholic beverages;
- Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
- Current treatment with medication or supplements which significantly affect the main studied variables;
- Bariatric surgery;
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 |
|---|---|---|
| Dietary and Exercise ApproachesIntermittent fasting plus energy restriction combined with aerobic exercise performed in a fasted state. | Behavioural | Time-Restricted Eating and Aerobic Exercise Performed in Fasted State |
| Dietary and Exercise ApproachesIntermittent fasting plus energy restriction combined with aerobic exercise performed in a fed state. | Behavioural | Time-Restricted Eating and Aerobic Exercise Performed in Fed State |
| Dietary ApproachIntermittent fasting plus energy restriction without aerobic exercise training. | Behavioural | Time-Restricted Eating |
Primary outcome
Insulin sensitivity (indices)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Including but not limited to the Sensitivity Matsuda index
23 secondary outcomes
Insulin resistance (indices)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting insulin levels (µIU/mL)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting glucose levels (mg/dL)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Glucose tolerance
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting lipid profile levels
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
β cell function (indices)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Mass (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Percentage (%)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Free Mass (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Time frame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Bone Mineral Content (kg)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Mass Index (kg/m^2)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Resting metabolic rate (Kcal/day)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Substrate Oxidation (respiratory exchange ratio)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Absolute Peak oxygen consumption
Time frame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Relative Peak oxygen consumption
Time frame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Fasting Leptin Levels
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting Adiponectin Levels
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Inflammatory Markers Levels
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
LDL-cholesterol levels
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Non-HDL-cholesterol levels
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and Exercise Approaches and Dietary Approach in people with Time Restricted Eating and Obesity, run by Federal University of Rio Grande do Sul.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Insulin sensitivity (indices) (time frame: Change from baseline. Measured at baseline and after 8 weeks.). 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 8 Mar 2024.