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Completed

NCT Number: NCT03393195

Study of Time-restricted Eating on Weight Loss.

This is a randomized controlled trial studying the effects of time-restricted eating (TRE) on weight loss in obese humans. Obesity is the number one risk factor for type 2 Diabetes Mellitus (T2DM), and numerous studies demonstrate that weight loss is an effective strategy to prevent T2DM and improve the metabolic health of people diagnosed with T2DM. Unfortunately, classical calorie restriction diets often fail to produce long-term weight loss due to low compliance, reduced resting metabolic rate (RMR), and other factors. Therefore, novel dieting techniques must be explored in order to successfully treat obesity and prevent T2DM. Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and metabolic health markers in the absence of calorie restriction. Limited research in human subjects suggests that this feeding paradigm may translate to human health as well, however, more research needs to be done in order to confirm this hypothesis. This study will determine if TRE can lead to weight loss in obese human subjects. Secondary outcomes include changes in body composition, HOMA-IR, hormonal and biochemical serum markers, RMR, and total energy expenditure (TEE).

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Medical Center

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI between 30-40 kg/m2
  • Participants must regularly consume breakfast (at least 5 days per week)
  • Must speak, read, and comprehend English
  • Access to reliable internet and/or wifi
  • Must have a valid email address and phone number
  • Must have a cellular phone with data plan

Exclusion criteria

  • HIV or immunocompromised
  • Current or past cancer diagnosis
  • Pregnant, breastfeeding, or planned pregnancy in next 6 months
  • Beginning or ending hormonal contraception in next 6 months
  • Current diagnosis of type or type 2 diabetes
  • Currently taking glucose-lowering drugs, statins, or oral steroids
  • History of gastric bypass surgery or any other weight-loss surgery
  • History of anorexia or bulimia
  • Frequent travel across time zones or unusual work hours
  • Unable to fast for prolonged periods due to medical condition
  • Unable to stand for several minutes without aid
  • Cannot lie down on cushioned table for 30 minutes
  • No internal metal artifacts that would alter body composition
  • Unable to travel to UCSF for in-person testing
  • Requires translator services

Treatment and study plan

Time-restricted Eating plan

Behavioral

Research team will prescribe an eating plan for the participant to follow for the 12 week study. The eating plan will consist of eating during a specified 8 hour window and fasting for the remaining 16 hours of the day.

Consistent Meal timing plan

Behavioral

Research team will prescribe an eating plan for the participant to follow for the 12 week study.The eating plan will consist of eating three structured meals each day during three specified meal windows.

Primary outcomes

  1. Weight Loss

    Time frame: Daily for 12 weeks

    Measure changes in weight during the 12 week study

Secondary outcomes

  1. Fat loss

    Time frame: Measured twice: Once at study start and once 12 weeks later

    Measure changes in fat mass during the 12 week study using DXA data

  2. Changes in lean mass

    Time frame: Measured twice: Once at study start and once 12 weeks later

    Measure changes in lean mass during the 12 week study using DXA data

  3. Fasting insulin levels

    Time frame: Measured twice: Once at study start and once 12 weeks later

    Measure fasting insulin levels pre and post intervention

  4. Resting metabolic rate

    Time frame: Measured twice: Once at study start and once 12 weeks later

    Will measure participants resting metabolic rate

  5. Total energy expenditure

    Time frame: Measured twice: Once at study start and once 12 weeks later

    Will measure participants total energy expenditure during the week leading up to the study start and during the final week of the study

  6. Changes in fasting glucose levels

    Time frame: Measured twice: Once at study start and once 12 weeks later

    WIll measure fasting blood glucose levels prior to diet intervention and again at study completion

  7. Changes in HbA1c levels

    Time frame: Measured twice: Once at study start and once 12 weeks later

    WIll measure HbA1c levels prior to diet intervention and again at study completion

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study title

Study of Time-restricted Eating on Weight Loss. A Randomized Controlled Trial of the Effects of Time-restricted Eating on Weight Loss in Obese Subjects.

Acronym: TREAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 8, 2018
Registry last updated
Mar 3, 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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