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

Not Applicable

Completed

• Conditions: Obesity; Time Restricted Feeding; Weight Loss; Calorie Restriction
• Interventions: Behavioral: Continuous Energy Restriction; Behavioral: Time restricted feeding

• Registration Number: NCT03745612
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Study Start: 2018-11-30
• Primary Completion: 2021-07-24
• Study Completion: 2021-07-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-12
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CER	Continuous Energy Restriction	continuous energy restriction
TRF	Time restricted feeding	Time restricted feeding

Primary Outcome Measures

Name	Time	Method
Change in body weight over 12 months	Baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
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
Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)	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 life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)	Baseline to 12 months

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China