NCT03745612

Brief Summary

Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on weight loss and cardiometabolic risk factors in obese adults over 12 months compared to continuous energy restriction (CER).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable obesity

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

November 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2021

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

November 15, 2018

Last Update Submit

November 12, 2023

Conditions

ObesityTime Restricted FeedingWeight LossCalorie Restriction

Outcome Measures

Primary Outcomes (1)

  • Change in body weight over 12 months

    Baseline to 12 months

Secondary Outcomes (13)

  • Change in body composition

    Baseline to 12 months

  • Change in waist circumference

    Baseline to 12 months

  • Change in liver fat

    Baseline to 12 months

  • Change in visceral fat

    Baseline to 12 months

  • Change in HbA1c

    Baseline to 12 months

  • +8 more secondary outcomes

Study Arms (2)

TRF

EXPERIMENTAL

Time restricted feeding

Behavioral: Time restricted feeding

CER

ACTIVE COMPARATOR

continuous energy restriction

Behavioral: Continuous Energy Restriction

Interventions

Time restricted feedingBEHAVIORAL

Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).

TRF
Continuous Energy RestrictionBEHAVIORAL

Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time.

CER

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male of female aged between 18 and 75 years old;
  • Body mass index (BMI)of 28.0 to 45.0 kg/m2;

You may not qualify if:

  • History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
  • Diagnosis of type 1 and type 2 diabetes;
  • History of malignant tumors;
  • Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
  • History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
  • History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
  • History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
  • Being a smoker or having been a smoker in the 3 months prior to their screening visit;
  • Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
  • Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
  • Women who are pregnant or plan to become pregnant;
  • Patients who cannot be followed for 24 months (due to a health situation or migration);
  • Patients who are unwilling or unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

  • Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833.

    PMID: 35443107RESULT

MeSH Terms

Conditions

ObesityIntermittent FastingWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehaviorBody Weight Changes

Study Officials

  • Huijie Zhang, MD,PhD

    Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 19, 2018

Study Start

November 30, 2018

Primary Completion

July 24, 2021

Study Completion

July 28, 2021

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)