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CompletedNCT03745612TREATYUpdated Nov 15, 2023

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

An interventional study of Time restricted feeding and Continuous Energy Restriction in Obesity, Time Restricted Feeding and Weight Loss, sponsored by Nanfang Hospital, Southern Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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).

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Conditions studied

  • Obesity
  • Time Restricted Feeding
  • Weight Loss
  • Calorie Restriction
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In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 139 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
139 participants (actual)

Study arms

  • Experimental
    TRF

    Time restricted feeding

    Behavioral: Time restricted feeding

  • Active comparator
    CER

    continuous energy restriction

    Behavioral: Continuous Energy Restriction

Interventions

  • BehavioralTime 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).

  • BehavioralContinuous 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.

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What researchers measure

Primary outcomes

  1. Change in body weight over 12 months

    Time frame: Baseline to 12 months

Secondary outcomes

  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

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Study locations

1 site
  • Nanfang Hospital of Southern Medical University
    Guangzhou, Guangdong 510515, China
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References and documents

Publications

  • 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. PubMed 35443107 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03745612
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Nov 19, 2018
Start date
Nov 30, 2018
Primary completion
Jul 24, 2021
Completion
Jul 28, 2021
Last update
Nov 15, 2023

Study contacts

Huijie Zhang, MD,PhD
principal investigator · Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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