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

Federal University of Rio Grande do Sul0 sites30 target enrollmentMarch 2024

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Time Restricted Eating
Sponsor: Federal University of Rio Grande do Sul
Enrollment: 30
Primary Endpoint: Insulin sensitivity (indices)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2024

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Federal University of Rio Grande do Sul

Responsible Party

Principal Investigator

Alvaro Reischak-Oliveira

Professor

Federal University of Rio Grande do Sul

Eligibility Criteria

Inclusion Criteria

•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;

Outcomes

Primary Outcomes

Insulin sensitivity (indices)

Time Frame: Change from baseline. Measured at baseline and after 8 weeks.

Including but not limited to the Sensitivity Matsuda index

Secondary Outcomes

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.)
Fat Mass (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
Fat Free Mass (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
Bone Mineral Content (kg)(Change from baseline. Measured at baseline and after 8 weeks.)
Absolute Peak oxygen consumption(Change from baseline. Measured at baseline and after 4, and 8 weeks.)
Fasting Adiponectin Levels(Change from baseline. Measured at baseline and after 8 weeks.)
LDL-cholesterol levels(Change from baseline. Measured at baseline and after 8 weeks.)
Non-HDL-cholesterol levels(Change from baseline. Measured at baseline and after 8 weeks.)
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.)
β cell function (indices)(Change from baseline. Measured at baseline and after 8 weeks.)
Fat Percentage (%)(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.)
Fasting lipid profile levels(Change from baseline. Measured at baseline and after 8 weeks.)
Body Mass Index (kg/m^2)(Change from baseline. Measured at baseline and after 8 weeks.)
Resting metabolic rate (Kcal/day)(Change from baseline. Measured at baseline and after 8 weeks.)
Substrate Oxidation (respiratory exchange ratio)(Change from baseline. Measured at baseline and after 8 weeks.)
Relative Peak oxygen consumption(Change from baseline. Measured at baseline and after 4, and 8 weeks.)
Body Weight (kg)(Change from baseline. Measured at baseline and after 4, and 8 weeks.)
Inflammatory Markers Levels(Change from baseline. Measured at baseline and after 8 weeks.)
Fasting Leptin Levels(Change from baseline. Measured at baseline and after 8 weeks.)