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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Polycystic Ovary Syndrome (PCOS)
• Intervention / Treatment: Behavioral: Time Restricted Feeding; Behavioral: Usual care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The first afilliated hospital of Xiamen university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRF; Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.	Behavioral: Time Restricted Feeding; 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).
Active Comparator: Usual care; Participants in this group will receive a general lifestyle counseling.	Behavioral: Usual care; Participants receive a general lifestyle counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight (Kilograms)	Changes in body weight (Kilograms)	Baseline and 16 weeks
Change in insulin resistance	Insulin resistance will be assessed by HOMA-IR	Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in waist circumference (cm)		Baseline and 16 weeks
Changes in abdominal circumference (cm)		Baseline and 16 weeks
Changes in systolic pressure（SBP）		Baseline and 16 weeks
Changes in diastolic pressure (DBP）		Baseline and 16 weeks
Change in β cell function	β cell function will be assessed by HOMA-β	Baseline and 16 weeks
Change in LDL-c level		Baseline and 16 weeks
Change in TG level		Baseline and 16 weeks
Change in CHO level		Baseline and 16 weeks
Change in liver fiber	liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan	Baseline and 16 weeks
Changes in systemic Inflammatory biomarkers	Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).	Baseline and 16 weeks
Changes in Oxidative stress markers	Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.	Baseline and 16 weeks
Change in depressive symptoms as assessed by Patient Health Questionnaire-9		Baseline and 16 weeks
Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)		Baseline and 16 weeks
Changes in time to return to normal menstrual cycle	Changes in time to return to normal menstrual cycle	Baseline and 16 weeks

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University
• Investigators: Principal Investigator: Changqin Liu, MD, The first afilliated hospital of Xiamen university

Publications and helpful links

General Publications

• Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: December 30, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; Overweight and Obesity; Time-Restricted Feeding; Intermittent fasting regimens
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Overnutrition; Nutrition Disorders; Body Weight; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Overweight
• Other Study ID Numbers: KYH2018-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No