Effects of Time-Restricted Feeding on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial

Nanfang Hospital, Southern Medical University1 site in 1 country139 target enrollmentNovember 30, 2018

ConditionsObesity Time Restricted Feeding Weight Loss Calorie Restriction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Nanfang Hospital, Southern Medical University
Enrollment: 139
Locations: 1
Primary Endpoint: Change in body weight over 12 months
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 30, 2018

End Date

July 28, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nanfang Hospital, Southern Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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) ;

Outcomes

Primary Outcomes

Change in body weight over 12 months

Time Frame: Baseline to 12 months

Secondary Outcomes

Change in blood lipids(Baseline to 12 months)
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)
Change in Blood pressure(Baseline to 12 months)
Change in insulin sensitivity(Baseline to 12 months)
Change in β cell function(Baseline to 12 months)
Change in pulse wave velocity (PWV)(Baseline to 12 months)
Depression measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline to 12 months)
Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)(Baseline to 12 months)
Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)(Baseline to 12 months)