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Completed

NCT Number: NCT03745612

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time restricted feeding

Behavioral

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

Behavioral

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 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

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Acronym: TREATY

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2018
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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