Study of Time-restricted Eating on Weight Loss. (TREAT)

February 28, 2020 updated by: University of California, San Francisco

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time-restricted eating plan
Participants in this group will be instructed to fast every day from 8pm until 12pm the following day. From 12pm until 8pm, participants can eat and drink whatever they want. During fasting hours, participants can drink water and black coffee.
Behavioral: Time-restricted Eating plan
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.
Active Comparator: Consistent Meal Timing Plan
Participants in this group will be instructed to eat three daily meals during specified eating times. Their first meal will be between 7am-11am. Second meal between 11am and 3pm, and third meal between 4pm-10pm. Participants will be encouraged to eat small snacks if needed so that they can eat their next meal during the specified window.
Behavioral: Consistent Meal timing plan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: Daily for 12 weeks
Measure changes in weight during the 12 week study
Daily for 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured twice: Once at study start and once 12 weeks later
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
Measured twice: Once at study start and once 12 weeks later
Fasting insulin levels
Time Frame: Measured twice: Once at study start and once 12 weeks later
Measure fasting insulin levels pre and post intervention
Measured twice: Once at study start and once 12 weeks later
Resting metabolic rate
Time Frame: Measured twice: Once at study start and once 12 weeks later
Will measure participants resting metabolic rate
Measured twice: Once at study start and once 12 weeks later
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
Measured twice: Once at study start and once 12 weeks later
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
Measured twice: Once at study start and once 12 weeks later
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
Measured twice: Once at study start and once 12 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Ethan J Weiss, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2018

Primary Completion (Actual)

October 23, 2019

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-22110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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