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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04647149
Other study ID # TRE_UFRGS#
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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