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

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ClinicalTrials.gov Identifier: NCT03393195
Recruitment Status : Active, not recruiting
First Posted : January 8, 2018
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE January 8, 2018
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE July 30, 2018
Actual Primary Completion Date October 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
Weight Loss [ Time Frame: Daily for 12 weeks ]
Measure changes in weight during the 12 week study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03393195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
  • 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
  • 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
  • Waist to hip ratio [ Time Frame: Measured twice: Once at study start and once 12 weeks later ]
    Measure changes in WHR during the 12 week study
  • Fasting insulin levels [ Time Frame: Measured twice: Once at study start and once 12 weeks later ]
    Measure fasting insulin levels pre and post intervention
  • Fasting cholesterol levels [ Time Frame: Measured twice: Once at study start and once 12 weeks later ]
    Measure fasting cholesterol levels pre and post intervention
  • Fasting adiponectin levels [ Time Frame: Measured twice: Once at study start and once 12 weeks later ]
    Measure fasting adiponectin levels pre and post intervention
  • Fasting leptin levels [ Time Frame: Measured pre and post intervention ]
    Measure fasting leptin levels pre and post intervention
  • Changes in muscle function [ Time Frame: Measured twice: Once at study start and once 12 weeks later ]
    Will measure isokinetic and isometric leg strength using biodex machine
  • Changes in sleep patterns [ Time Frame: Monthly for three months. Survey will be completed 4 times ]
    Will use the validated Pittsburgh Sleep Quality index to record participatns amount and quality of sleep
  • Changes in blood pressure [ Time Frame: Daily for 12 weeks ]
    Will monitor blood pressure daily using the at-home MOCACAE bluetooth blood pressure cuff
  • Calorie intake [ Time Frame: Bi-monthly for three months. Survey will be completed 6 times ]
    Will estimate participants energy intake using the ASA24 (from National Cancer Institute)
  • Resting metabolic rate [ Time Frame: Measured twice: Once at study start and once 12 weeks later ]
    Will measure participants resting metabolic rate
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Time-restricted Eating on Weight Loss.
Official Title  ICMJE 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.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Obesity
  • Insulin Resistance
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Time-restricted Eating plan
  • 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.
    Intervention: Behavioral: Consistent Meal timing plan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
150
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2018)
100
Estimated Study Completion Date  ICMJE January 10, 2020
Actual Primary Completion Date October 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03393195
Other Study ID Numbers  ICMJE 17-22110
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE University of Wisconsin, Madison
Investigators  ICMJE
Principal Investigator: Ethan J Weiss, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP