Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity

Obesity Clinical Trial

Official title:

Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647149
• Other study ID #: TRE_UFRGS#
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: May 12, 2020

Study information

• Verified date: November 2020
• 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 some cardiometabolic risk factors have been reported. However, there is a lack of randomized clinical trials that directly investigate the effect of TRE at different times of the day (early vs. delayed) in individuals with overweight and obesity. The present study investigates the effects of 8 weeks of TRE performed at different moments of the day on body composition and cardiometabolic parameters in adults with overweight and obesity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 12, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male and 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 prior to the beginning of the study;
• Able to give written informed consent.

Exclusion Criteria:

• Current smoker;
• Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc);
• Current treatment with medication or supplements which significantly affect the main studied variables;
• Night-shift workers;
• Night eating syndrome;
• Irregular sleep patterns;
• For women: pregnancy, planned pregnancy (within the study period), lactating or menopause;
• Habitual fasting window >16 hours;
• Concomitant participation in other studies.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Dietary Approach
Dietary approaches with energy restriction performed at different times of the day.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Fasting insulin levels (µIU/mL)	Measured by enzyme-Linked Immunosorbent Assay	Change from baseline. Measured at baseline and after 8 weeks.
Primary	Fasting glucose levels (mg/dL)	Measured by colorimetric method	Change from baseline. Measured at baseline and after 8 weeks.
Primary	Insulin Sensitivity (indices)	Including but not limited to the Matsuda index	Change from baseline. Measured at baseline and after 8 weeks.
Primary	Glucose tolerance	Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)	Change from baseline. Measured at baseline and after 8 weeks.
Primary	Fasting lipid profile levels (mg/dL)	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-BETA	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	Peak oxygen consumption (mL/min and mL/kg/min)	Measured by an open-circuit spirometry system	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Quality of sleep	Measured by Pittsburgh Sleep Quality Index Questionnaire. Higher scores indicate worse sleep quality.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Risk of binge eating	Measured by binge eating scale. Higher scores indicate greater risk of binge eating.	Change from baseline. Measured at baseline and after 8 weeks.
Secondary	Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat).	Measured by visual analog scale.The scale range is 0-100 mm and each end represent the extremes.	Change from baseline. Measured at baseline and after 8 weeks.