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

• ClinicalTrials.gov Identifier: NCT03745612
• Recruitment Status: Completed
• First Posted: November 19, 2018
• Last Update Posted: November 15, 2023
• Sponsor: Nanfang Hospital, Southern Medical University
• Information provided by (Responsible Party): Nanfang Hospital, Southern Medical University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Obesity; Time Restricted Feeding; Weight Loss; Calorie Restriction	Behavioral: Time restricted feeding; Behavioral: Continuous Energy Restriction	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Time-Restricted Feeding on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
• Actual Study Start Date: November 30, 2018
• Actual Primary Completion Date: July 24, 2021
• Actual Study Completion Date: July 28, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: TRF; Time restricted feeding	Behavioral: Time restricted feeding; 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).
Active Comparator: CER; continuous energy restriction	Behavioral: Continuous Energy Restriction; Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time.

Outcome Measures

Primary Outcome Measures :

1. Change in body weight over 12 months [ Time Frame: Baseline to 12 months ]

Secondary Outcome Measures :

1. Change in body composition [ Time Frame: Baseline to 12 months ]
2. Change in waist circumference [ Time Frame: Baseline to 12 months ]
3. Change in liver fat [ Time Frame: Baseline to 12 months ]
4. Change in visceral fat [ Time Frame: Baseline to 12 months ]
5. Change in HbA1c [ Time Frame: Baseline to 12 months ]
6. Change in Blood pressure [ Time Frame: Baseline to 12 months ]
7. Change in blood lipids [ Time Frame: Baseline to 12 months ]
8. Change in insulin sensitivity [ Time Frame: Baseline to 12 months ]
9. Change in β cell function [ Time Frame: Baseline to 12 months ]
10. Change in pulse wave velocity (PWV) [ Time Frame: Baseline to 12 months ]
11. Depression measured by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline to 12 months ]
12. Quality of sleep measured by the Pittsburgh sleep quality index (PSQI) [ Time Frame: Baseline to 12 months ]
13. Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) [ Time Frame: Baseline to 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China, Guangdong

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510515

Sponsors and Collaborators

Nanfang Hospital, Southern Medical University

Investigators

• Principal Investigator: Huijie Zhang, MD,PhD; Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

More Information

Publications of Results:

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.

• Responsible Party: Nanfang Hospital, Southern Medical University
• ClinicalTrials.gov Identifier: NCT03745612
• Other Study ID Numbers: NFEC-2018-145
• First Posted: November 19, 2018
• Last Update Posted: November 15, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Body Weight; Weight Loss; Body Weight Changes