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Completed

NCT Number: NCT04647149

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

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.

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Key information

Conditions

Time Restricted Feeding Behavior Body Weight Fasting Feeding Behavior Intermittent Fasting Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Sul

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Approach

Behavioral

Dietary approaches with energy restriction performed at different times of the day.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 30, 2020
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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