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

NCT ID: NCT06302231

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Time-Restricted Eating and Aerobic Exercise Performed in Fasted State

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.

Group Type EXPERIMENTAL

Dietary and Exercise Approaches

Intervention Type BEHAVIORAL

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

Time-Restricted Eating and Aerobic Exercise Performed in Fed State

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.

Group Type ACTIVE_COMPARATOR

Dietary and Exercise Approaches

Intervention Type BEHAVIORAL

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

Time-Restricted Eating

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.

Group Type OTHER

Dietary Approach

Intervention Type BEHAVIORAL

Intermittent fasting plus energy restriction without aerobic exercise training.

Interventions

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Dietary and Exercise Approaches

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

Intervention Type BEHAVIORAL

Dietary and Exercise Approaches

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

Intervention Type BEHAVIORAL

Dietary Approach

Intermittent fasting plus energy restriction without aerobic exercise training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Alvaro Reischak-Oliveira

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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16690919.5.0000.5347

Identifier Type: -

Identifier Source: org_study_id

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