Time Restricted Feeding on Weight Loss and Cardio-protection (TREATY Trial)

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Calorie Restriction; Weight Loss; Time Restricted Feeding; Obesity

Treatments: Behavioral: Continuous Energy Restriction; Behavioral: Time restricted feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT03745612

NFEC-2018-145

Details and patient eligibility

About

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).

Enrollment: 139 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

139 participants in 2 patient groups

TRF

Experimental group

Description:

Time restricted feeding

Treatment:

Behavioral: Time restricted feeding

CER

Active Comparator group

Description:

continuous energy restriction

Treatment:

Behavioral: Continuous Energy Restriction