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

Primary Purpose

Obesity, Time Restricted Feeding, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Time restricted feeding

Continuous Energy Restriction

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Nanfang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRF

CER

Arm Description

Time restricted feeding

continuous energy restriction

Outcomes

Primary Outcome Measures

Change in body weight over 12 months

Secondary Outcome Measures

Change in body composition

Change in waist circumference

Change in liver fat

Change in visceral fat

Change in HbA1c

Change in Blood pressure

Change in blood lipids

Change in insulin sensitivity

Change in β cell function

Change in pulse wave velocity (PWV)

Depression measured by the Patient Health Questionnaire-9 (PHQ-9)

Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)

Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)

Full Information

NCT ID

NCT03745612

First Posted

November 15, 2018

Last Updated

January 8, 2022

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03745612

Brief Title

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

Acronym

TREATY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

November 30, 2018 (Actual)

Primary Completion Date

July 24, 2021 (Actual)

Study Completion Date

July 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Time Restricted Feeding, Weight Loss, Calorie Restriction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRF

Arm Type

Experimental

Arm Description

Time restricted feeding

Arm Title

CER

Arm Type

Active Comparator

Arm Description

continuous energy restriction

Intervention Type

Behavioral

Intervention Name(s)

Time restricted feeding

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Continuous Energy Restriction

Intervention Description

Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time.

Primary Outcome Measure Information:

Title

Change in body weight over 12 months

Time Frame

Baseline to 12 months

Secondary Outcome Measure Information:

Title

Change in body composition

Time Frame

Baseline to 12 months

Title

Change in waist circumference

Time Frame

Baseline to 12 months

Title

Change in liver fat

Time Frame

Baseline to 12 months

Title

Change in visceral fat

Time Frame

Baseline to 12 months

Title

Change in HbA1c

Time Frame

Baseline to 12 months

Title

Change in Blood pressure

Time Frame

Baseline to 12 months

Title

Change in blood lipids

Time Frame

Baseline to 12 months

Title

Change in insulin sensitivity

Time Frame

Baseline to 12 months

Title

Change in β cell function

Time Frame

Baseline to 12 months

Title

Change in pulse wave velocity (PWV)

Time Frame

Baseline to 12 months

Title

Depression measured by the Patient Health Questionnaire-9 (PHQ-9)

Time Frame

Baseline to 12 months

Title

Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)

Time Frame

Baseline to 12 months

Title

Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)

Time Frame

Baseline to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male of female aged between 18 and 75 years old; Body mass index (BMI)of 28.0 to 45.0 kg/m2; Exclusion Criteria: History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis; Diagnosis of type 1 and type 2 diabetes; History of malignant tumors; 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); History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months; History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity; Being a smoker or having been a smoker in the 3 months prior to their screening visit; 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; Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ; Women who are pregnant or plan to become pregnant; Patients who cannot be followed for 24 months (due to a health situation or migration); Patients who are unwilling or unable to give informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huijie Zhang, MD,PhD

Organizational Affiliation

Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanfang Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35443107

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.

Results Reference

derived

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

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