Clinical trial NCT04647149: Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
Official title: Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Feeding
Intermittent Fasting
Obesity
Overweight and Obesity
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 48
Sex: ALL
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 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.


Eligibility criteria: 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.

Primary 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: Insulin Sensitivity (indices)
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 (mg/dL)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
Secondary outcomes:
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: Peak oxygen consumption (mL/min and mL/kg/min)
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Quality of sleep
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Risk of binge eating
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
measure: Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat).
timeFrame: Change from baseline. Measured at baseline and after 8 weeks.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Alvaro Reischak-Oliveira
role: PRINCIPAL_INVESTIGATOR
References: