Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity
- Conditions
- ObesityTime Restricted FeedingTime Restricted EatingIntermittent FastingOverweight and Obesity
- Interventions
- Behavioral: Dietary and Exercise ApproachesBehavioral: Dietary Approach
- Registration Number
- NCT06302231
- Lead Sponsor
- Federal University of Rio Grande do Sul
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- 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.
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Time-Restricted Eating and Aerobic Exercise Performed in Fasted State Dietary and Exercise Approaches 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. Time-Restricted Eating and Aerobic Exercise Performed in Fed State Dietary and Exercise Approaches 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. Time-Restricted Eating Dietary Approach 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.
- Primary Outcome Measures
Name Time Method Insulin sensitivity (indices) Change from baseline. Measured at baseline and after 8 weeks. Including but not limited to the Sensitivity Matsuda index
- Secondary Outcome Measures
Name Time Method Fasting ketones (β-hydroxybutyrate) levels (mmol/L) Change from baseline. Measured at baseline and after 8 weeks. Glucose tolerance Change from baseline. Measured at baseline and after 8 weeks. Measured by oral glucose tolerance test (2-h OGTT)
Fat Mass (kg) Change from baseline. Measured at baseline and after 8 weeks. Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Fat Free Mass (kg) Change from baseline. Measured at baseline and after 8 weeks. Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Bone Mineral Content (kg) Change from baseline. Measured at baseline and after 8 weeks. Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Absolute Peak oxygen consumption Change from baseline. Measured at baseline and after 4, and 8 weeks. Measured by an open-circuit spirometry system. Absolute value expressed in litres of oxygen per minute (L/min).
Fasting Adiponectin Levels Change from baseline. Measured at baseline and after 8 weeks. Measured by enzyme-Linked Immunosorbent Assay
LDL-cholesterol levels Change from baseline. Measured at baseline and after 8 weeks. Measured using the Friedewald equation.
Non-HDL-cholesterol levels Change from baseline. Measured at baseline and after 8 weeks. Calculated as total cholesterol minus HDL-cholesterol.
Insulin resistance (indices) Change from baseline. Measured at baseline and after 8 weeks. Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Fasting insulin levels (µIU/mL) Change from baseline. Measured at baseline and after 8 weeks. Measured by enzyme-Linked Immunosorbent Assay
β cell function (indices) Change from baseline. Measured at baseline and after 8 weeks. Including but not limited to HOMA-β
Fat Percentage (%) Change from baseline. Measured at baseline and after 8 weeks. Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Fasting glucose levels (mg/dL) Change from baseline. Measured at baseline and after 8 weeks. Measured by colorimetric method
Fasting lipid profile levels Change from baseline. Measured at baseline and after 8 weeks. Measured by colorimetric method
Body Mass Index (kg/m^2) Change from baseline. Measured at baseline and after 8 weeks. Calculated from weight in kilograms divided by height in meters squared.
Resting metabolic rate (Kcal/day) Change from baseline. Measured at baseline and after 8 weeks. Measured by indirect calorimetry under resting and fasting conditions.
Substrate Oxidation (respiratory exchange ratio) Change from baseline. Measured at baseline and after 8 weeks. Measured by indirect calorimetry under resting and fasting conditions.
Relative Peak oxygen consumption Change from baseline. Measured at baseline and after 4, and 8 weeks. Measured by an open-circuit spirometry system. Relative to body weight and expressed in milliliters of oxygen per minute (mL/kg/min).
Body Weight (kg) Change from baseline. Measured at baseline and after 4, and 8 weeks. Measured on a digital scale.
Inflammatory Markers Levels Change from baseline. Measured at baseline and after 8 weeks. Including but not limited to TNF-α (tumor necrosis factor-alpha) and IL-10 (Interleukin-10); Measured by enzyme-Linked Immunosorbent Assay
Fasting Leptin Levels Change from baseline. Measured at baseline and after 8 weeks. Measured by enzyme-Linked Immunosorbent Assay