Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity

NCT06302231 | Not Yet Recruiting

• 1 other identifier: 16690919.5.0000.5347
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Time Restricted Eating; Obesity; Intermittent Fasting; Overweight and Obesity; Time Restricted Feeding

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity (indices)

  Including but not limited to the Sensitivity Matsuda index

  Change from baseline. Measured at baseline and after 8 weeks.

Secondary Outcomes (23)

• Insulin resistance (indices)

  Change from baseline. Measured at baseline and after 8 weeks.

• Fasting insulin levels (µIU/mL)

  Change from baseline. Measured at baseline and after 8 weeks.

• Fasting glucose levels (mg/dL)

  Change from baseline. Measured at baseline and after 8 weeks.

• Glucose tolerance

  Change from baseline. Measured at baseline and after 8 weeks.

• Fasting lipid profile levels

  Change from baseline. Measured at baseline and after 8 weeks.

Study Arms (3)

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.

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.

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.

Behavioral: Dietary Approach

Interventions

Dietary and Exercise Approaches BEHAVIORAL

Intermittent fasting plus energy restriction combined with aerobic exercise performed in a fasted state.

Time-Restricted Eating and Aerobic Exercise Performed in Fasted State

Dietary Approach BEHAVIORAL

Intermittent fasting plus energy restriction without aerobic exercise training.

Time-Restricted Eating

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

MeSH Terms

Conditions

Intermittent Fasting; Obesity; Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03