An interventional study of Dietary Approach in Time Restricted Feeding, Intermittent Fasting and Obesity, sponsored by Federal University of Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 48 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Federal University of Rio Grande do Sul is the lead sponsor of 118 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8-hour eating window between 08:00 and 16:00
Behavioral: Dietary Approach
8-hour eating window between 12:00 and 20:00
Behavioral: Dietary Approach
12-hour eating window between 08:00 and 20:00
Behavioral: Dietary Approach
Dietary approaches with energy restriction performed at different times of the day.
Insulin resistance (indices)
Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting insulin levels (µIU/mL)
Measured by enzyme-Linked Immunosorbent Assay
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting glucose levels (mg/dL)
Measured by colorimetric method
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Insulin Sensitivity (indices)
Including but not limited to the Matsuda index
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Glucose tolerance
Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting lipid profile levels (mg/dL)
Measured by colorimetric method
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
β cell function (indices)
Including but not limited to HOMA-BETA
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Percentage (%)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fat Free Mass (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Weight (kg)
Measured on a digital scale.
Time frame: Change from baseline. Measured at baseline and after 4, and 8 weeks.
Bone Mineral Content (kg)
Measured by Dual-energy X-ray Absorptiometry under fasting condition.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Body Mass Index (kg/m^2)
Calculated from weight in kilograms divided by height in meters squared.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Fasting ketones (β-hydroxybutyrate) levels (mmol/L)
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Resting metabolic rate (Kcal/day)
Measured by indirect calorimetry under resting and fasting conditions.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Substrate Oxidation (respiratory exchange ratio)
Measured by indirect calorimetry under resting and fasting conditions.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Peak oxygen consumption (mL/min and mL/kg/min)
Measured by an open-circuit spirometry system
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Quality of sleep
Measured by Pittsburgh Sleep Quality Index Questionnaire. Higher scores indicate worse sleep quality.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
Risk of binge eating
Measured by binge eating scale. Higher scores indicate greater risk of binge eating.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
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.
Time frame: Change from baseline. Measured at baseline and after 8 weeks.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Federal University of Rio Grande do Sul