NCT03393195

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

December 20, 2017

Last Update Submit

February 28, 2020

Conditions

ObesityInsulin Resistance

Keywords

Weight lossDietTime-restricted feeding

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    Measure changes in weight during the 12 week study

    Daily for 12 weeks

Secondary Outcomes (7)

  • Fat loss

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

  • Changes in lean mass

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

  • Fasting insulin levels

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

  • Resting metabolic rate

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

  • Total energy expenditure

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

  • +2 more secondary outcomes

Study Arms (2)

Time-restricted eating plan

EXPERIMENTAL

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

Consistent Meal Timing Plan

ACTIVE COMPARATOR

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

Interventions

Time-restricted Eating planBEHAVIORAL

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.

Time-restricted eating plan
Consistent Meal timing planBEHAVIORAL

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.

Consistent Meal Timing Plan

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (2)

  • Wong MC, Bennett JP, Leong LT, Tian IY, Liu YE, Kelly NN, McCarthy C, Wong JMW, Ebbeling CB, Ludwig DS, Irving BA, Scott MC, Stampley J, Davis B, Johannsen N, Matthews R, Vincellette C, Garber AK, Maskarinec G, Weiss E, Rood J, Varanoske AN, Pasiakos SM, Heymsfield SB, Shepherd JA. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry. Am J Clin Nutr. 2023 Apr;117(4):802-813. doi: 10.1016/j.ajcnut.2023.02.006. Epub 2023 Feb 14.

    PMID: 36796647DERIVED

  • Lowe DA, Wu N, Rohdin-Bibby L, Moore AH, Kelly N, Liu YE, Philip E, Vittinghoff E, Heymsfield SB, Olgin JE, Shepherd JA, Weiss EJ. Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1491-1499. doi: 10.1001/jamainternmed.2020.4153.

    PMID: 32986097DERIVED

MeSH Terms

Conditions

ObesityInsulin ResistanceWeight LossIntermittent Fasting

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBody Weight ChangesFastingFeeding BehaviorBehavior

Study Officials

  • Ethan J Weiss, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial. Participants will randomly assigned to one of two diet interventions for the duration of the 12-week study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 8, 2018

Study Start

July 30, 2018

Primary Completion

October 23, 2019

Study Completion

January 10, 2020

Last Updated

March 3, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)