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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393195
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Behavioral: Time-restricted Eating plan Behavioral: Consistent Meal timing plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized controlled trial. Participants will randomly assigned to one of two diet interventions for the duration of the 12-week study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : October 23, 2019
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Weight Loss [ Time Frame: Daily for 12 weeks ]
    Measure changes in weight during the 12 week study


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393195


Locations
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United States, California
UCSF Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
University of Wisconsin, Madison
Investigators
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Principal Investigator: Ethan J Weiss, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03393195    
Other Study ID Numbers: 17-22110
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Weight loss
Diet
Time-restricted feeding
Additional relevant MeSH terms:
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Insulin Resistance
Weight Loss
Body Weight Changes
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases