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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302231
• Other study ID #: 16690919.5.0000.5347
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Dietary and Exercise Approaches
Intermittent fasting plus energy restriction combined with aerobic exercise performed in a fasted state.
• Dietary and Exercise Approaches
Intermittent fasting plus energy restriction combined with aerobic exercise performed in a fed state.
• Dietary Approach
Intermittent fasting plus energy restriction without aerobic exercise training.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity (indices)	Including but not limited to the Sensitivity Matsuda index	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Insulin resistance (indices)	Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fasting insulin levels (µIU/mL)	Measured by enzyme-Linked Immunosorbent Assay	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fasting glucose levels (mg/dL)	Measured by colorimetric method	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Glucose tolerance	Measured by oral glucose tolerance test (2-h OGTT)	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fasting lipid profile levels	Measured by colorimetric method	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	ß cell function (indices)	Including but not limited to HOMA-ß	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fat Mass (kg)	Measured by Dual-energy X-ray Absorptiometry under fasting condition.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fat Percentage (%)	Measured by Dual-energy X-ray Absorptiometry under fasting condition.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fat Free Mass (kg)	Measured by Dual-energy X-ray Absorptiometry under fasting condition.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Body Weight (kg)	Measured by Dual-energy X-ray Absorptiometry under fasting condition.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Body Weight (kg)	Measured on a digital scale.	Change from baseline. Measured at baseline and after 4, and 8 weeks.
Secondary	Bone Mineral Content (kg)	Measured by Dual-energy X-ray Absorptiometry under fasting condition.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Body Mass Index (kg/m^2)	Calculated from weight in kilograms divided by height in meters squared.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fasting ketones (ß-hydroxybutyrate) levels (mmol/L)		Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Resting metabolic rate (Kcal/day)	Measured by indirect calorimetry under resting and fasting conditions.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Substrate Oxidation (respiratory exchange ratio)	Measured by indirect calorimetry under resting and fasting conditions.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Absolute Peak oxygen consumption	Measured by an open-circuit spirometry system. Absolute value expressed in litres of oxygen per minute (L/min).	Change from baseline. Measured at baseline and after 4, and 8 weeks.
Secondary	Relative Peak oxygen consumption	Measured by an open-circuit spirometry system. Relative to body weight and expressed in milliliters of oxygen per minute (mL/kg/min).	Change from baseline. Measured at baseline and after 4, and 8 weeks.
Secondary	Fasting Leptin Levels	Measured by enzyme-Linked Immunosorbent Assay	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Fasting Adiponectin Levels	Measured by enzyme-Linked Immunosorbent Assay	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Inflammatory Markers Levels	Including but not limited to TNF-a (tumor necrosis factor-alpha) and IL-10 (Interleukin-10); Measured by enzyme-Linked Immunosorbent Assay	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	LDL-cholesterol levels	Measured using the Friedewald equation.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Non-HDL-cholesterol levels	Calculated as total cholesterol minus HDL-cholesterol.	Change from baseline. Measured at baseline and after 8 weeks.