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

• ClinicalTrials.gov Identifier: NCT04647149
• Recruitment Status: Completed
• First Posted: November 30, 2020
• Last Update Posted: November 30, 2020
• Sponsor: Federal University of Rio Grande do Sul
• Information provided by (Responsible Party): Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Time Restricted Feeding; Intermittent Fasting; Obesity; Overweight and Obesity	Behavioral: Dietary Approach	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Early and Delayed Time-Restricted Eating on Body Weight and Metabolic Parameters in Adults With Overweight and Obesity
• Actual Study Start Date: September 3, 2019
• Actual Primary Completion Date: May 12, 2020
• Actual Study Completion Date: May 12, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early Time-Restricted Eating; 8-hour eating window between 08:00 and 16:00	Behavioral: Dietary Approach; Dietary approaches with energy restriction performed at different times of the day.
Experimental: Delayed Time-Restricted Eating; 8-hour eating window between 12:00 and 20:00	Behavioral: Dietary Approach; Dietary approaches with energy restriction performed at different times of the day.
Experimental: Control; 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.

Outcome Measures

Primary Outcome Measures :

1. Insulin resistance (indices) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
2. Fasting insulin levels (µIU/mL) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by enzyme-Linked Immunosorbent Assay
3. Fasting glucose levels (mg/dL) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by colorimetric method
4. Insulin Sensitivity (indices) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Including but not limited to the Matsuda index
5. Glucose tolerance [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by oral glucose tolerance test (OGTT; 0,30,60,90, and 120 min)
6. Fasting lipid profile levels (mg/dL) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by colorimetric method

Secondary Outcome Measures :

1. β cell function (indices) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Including but not limited to HOMA-BETA
2. Fat Mass (kg) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by Dual-energy X-ray Absorptiometry under fasting condition.
3. Fat Percentage (%) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by Dual-energy X-ray Absorptiometry under fasting condition.
4. Fat Free Mass (kg) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by Dual-energy X-ray Absorptiometry under fasting condition.
5. Body Weight (kg) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by Dual-energy X-ray Absorptiometry under fasting condition.
6. Body Weight (kg) [ Time Frame: Change from baseline. Measured at baseline and after 4, and 8 weeks. ]
   Measured on a digital scale.
7. Bone Mineral Content (kg) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Measured by Dual-energy X-ray Absorptiometry under fasting condition.
8. Body Mass Index (kg/m^2) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
   Calculated from weight in kilograms divided by height in meters squared.
9. Fasting ketones (β-hydroxybutyrate) levels (mmol/L) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
10. Resting metabolic rate (Kcal/day) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
    Measured by indirect calorimetry under resting and fasting conditions.
11. Substrate Oxidation (respiratory exchange ratio) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
    Measured by indirect calorimetry under resting and fasting conditions.
12. Peak oxygen consumption (mL/min and mL/kg/min) [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
    Measured by an open-circuit spirometry system
13. Quality of sleep [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
    Measured by Pittsburgh Sleep Quality Index Questionnaire. Higher scores indicate worse sleep quality.
14. Risk of binge eating [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
    Measured by binge eating scale. Higher scores indicate greater risk of binge eating.
15. Subjective appetite parameters (hunger, fullness, prospective food consumption, and desire to eat). [ Time Frame: Change from baseline. Measured at baseline and after 8 weeks. ]
    Measured by visual analog scale.The scale range is 0-100 mm and each end represent the extremes.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Brazil

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200

Sponsors and Collaborators

Federal University of Rio Grande do Sul

Investigators

• Principal Investigator: Alvaro Reischak-Oliveira; Federal University of Rio Grande do Sul

More Information

• Responsible Party: Alvaro Reischak-Oliveira, Professor, Federal University of Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT04647149
• Other Study ID Numbers: TRE_UFRGS#
• First Posted: November 30, 2020
• Last Update Posted: November 30, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight