Clinical trial NCT03745612: Time Restricted Feeding on Weight Loss and Cardio-protection (TREATY Trial)
Official title: Effects of Time-Restricted Feeding on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Time Restricted Feeding
Weight Loss
Calorie Restriction
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
2. Diagnosis of type 1 and type 2 diabetes;
3. History of malignant tumors;
4. 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);
5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
6. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
7. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
8. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
9. 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;
10. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
11. Women who are pregnant or plan to become pregnant;
12. Patients who cannot be followed for 24 months (due to a health situation or migration);
13. Patients who are unwilling or unable to give informed consent.

Primary outcomes:
measure: Change in body weight over 12 months
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in body composition
timeFrame: Baseline to 12 months
measure: Change in waist circumference
timeFrame: Baseline to 12 months
measure: Change in liver fat
timeFrame: Baseline to 12 months
measure: Change in visceral fat
timeFrame: Baseline to 12 months
measure: Change in HbA1c
timeFrame: Baseline to 12 months
measure: Change in Blood pressure
timeFrame: Baseline to 12 months
measure: Change in blood lipids
timeFrame: Baseline to 12 months
measure: Change in insulin sensitivity
timeFrame: Baseline to 12 months
measure: Change in β cell function
timeFrame: Baseline to 12 months
measure: Change in pulse wave velocity (PWV)
timeFrame: Baseline to 12 months
measure: Depression measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline to 12 months
measure: Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline to 12 months
measure: Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
name: Huijie Zhang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.