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

Obesity Clinical Trial

— TREATY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745612
• Other study ID #: NFEC-2018-145
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: July 28, 2021

Study information

• Verified date: November 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: July 28, 2021
• Est. primary completion date: July 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Calorie Restriction
• Obesity
• Time Restricted Feeding
• Weight Loss

Intervention

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).
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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/NEJMo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight over 12 months		Baseline to 12 months
Secondary	Change in body composition		Baseline to 12 months
Secondary	Change in waist circumference		Baseline to 12 months
Secondary	Change in liver fat		Baseline to 12 months
Secondary	Change in visceral fat		Baseline to 12 months
Secondary	Change in HbA1c		Baseline to 12 months
Secondary	Change in Blood pressure		Baseline to 12 months
Secondary	Change in blood lipids		Baseline to 12 months
Secondary	Change in insulin sensitivity		Baseline to 12 months
Secondary	Change in ß cell function		Baseline to 12 months
Secondary	Change in pulse wave velocity (PWV)		Baseline to 12 months
Secondary	Depression measured by the Patient Health Questionnaire-9 (PHQ-9)		Baseline to 12 months
Secondary	Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)		Baseline to 12 months
Secondary	Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)		Baseline to 12 months