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Completed

NCT Number: NCT03792282

Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome (PCOS)

The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.

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Key information

About this study

Intermittent fasting regimens involve periods fasting followed by periods of eating freely. Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in adults with obesity. Accumulating evidence suggests that TRF is an effective means of decreasing body weight and improving insulin resistance but did not have any negative impact on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70 % of women with PCOS are obese or overweight, and obesity is associated with insulin resistance. Since many women with PCOS seem to have insulin resistance, compensatory hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine whether TRF is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese PCOS patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • BMI≥24kg/m2
  • Polycystic ovary syndrome has been diagnosed

Exclusion criteria

  • 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;
  • The body weight fluctuated more than 5% in recent 3 months.
  • Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
  • History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
  • History of thyroid diseases;
  • Having been in pregnancy.
  • Researchers believe that there are any factors that affect assessing subjects' participation in trial.
  • History of malignant tumors;
  • History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
  • Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight)
  • Patients who cannot be followed for 16 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 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).

Usual Care

Behavioral

Participants receive a general lifestyle counseling.

Primary outcomes

  1. Changes in body weight (Kilograms)

    Time frame: Baseline and 16 weeks

    Changes in body weight (Kilograms)

  2. Change in insulin resistance

    Time frame: Baseline and 16 weeks

    Insulin resistance will be assessed by HOMA-IR

Secondary outcomes

  1. Change in BMI

    Time frame: Baseline and 16 weeks

  2. Changes in waist circumference (cm)

    Time frame: Baseline and 16 weeks

  3. Changes in Waist-to-Hip Ratio(WHR)

    Time frame: Baseline and 16 weeks

  4. Changes in systolic pressure(SBP)

    Time frame: Baseline and 16 weeks

  5. Changes in diastolic pressure (DBP)

    Time frame: Baseline and 16 weeks

  6. Change in Body fat percent

    Time frame: Baseline and 16 weeks

  7. Change in Fat mass

    Time frame: Baseline and 16 weeks

  8. Change in Skeletal muscle mass

    Time frame: Baseline and 16 weeks

  9. Change in CHO level

    Time frame: Baseline and 16 weeks

  10. Change in TG level

    Time frame: Baseline and 16 weeks

  11. Change in HDL level

    Time frame: Baseline and 16 weeks

  12. Change in LDL-c level

    Time frame: Baseline and 16 weeks

  13. Change in Fasting Blood Glucose (FBG) level

    Time frame: Baseline and 16 weeks

  14. Change in ALT level

    Time frame: Baseline and 16 weeks

  15. Change in AST level

    Time frame: Baseline and 16 weeks

  16. Change in GGT level

    Time frame: Baseline and 16 weeks

  17. Change in Testosterone level

    Time frame: Baseline and 16 weeks

  18. Change in Sex hormone binding globulin (SHBG) level

    Time frame: baseline and 16 weeks

  19. Change in Free androgen index (FAI)

    Time frame: Basline and 16 weeks

  20. Change in Ferriman-Gallway score (F-G score:)

    Time frame: Baseline and 16 weeks

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome(PCOS): a Randomized Controlled Trial

Acronym: TRF-PCOS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2019
Registry last updated
Feb 18, 2025

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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