Clinical trial NCT06302231: Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Time Restricted Eating
Obesity
Intermittent Fasting
Overweight and Obesity
Time Restricted Feeding
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insulin sensitivity (indices)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
Secondary outcomes:
measure: Insulin resistance (indices)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fasting insulin levels (µIU/mL)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fasting glucose levels (mg/dL)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Glucose tolerance
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fasting lipid profile levels
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: β cell function (indices)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fat Mass (kg)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fat Percentage (%)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fat Free Mass (kg)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Body Weight (kg)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Body Weight (kg)
timeFrame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
measure: Bone Mineral Content (kg)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Body Mass Index (kg/m^2)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Resting metabolic rate (Kcal/day)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Substrate Oxidation (respiratory exchange ratio)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Absolute Peak oxygen consumption
timeFrame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
measure: Relative Peak oxygen consumption
timeFrame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
measure: Fasting Leptin Levels
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Fasting Adiponectin Levels
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Inflammatory Markers Levels
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: LDL-cholesterol levels
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Non-HDL-cholesterol levels
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
Other outcomes:
Locations:
Study officials:
References: