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

Overweight and Obesity Clinical Trial

— TRF-PCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792282
• Other study ID #: KYH2018-017
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)
• Syndrome

Intervention

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).
• Usual care
Participants receive a general lifestyle counseling.

Locations

Country	Name	City	State
China	The first afilliated hospital of Xiamen university	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight (Kilograms)	Changes in body weight (Kilograms)	Baseline and 16 weeks
Primary	Change in insulin resistance	Insulin resistance will be assessed by HOMA-IR	Baseline and 16 weeks
Secondary	Changes in waist circumference (cm)		Baseline and 16 weeks
Secondary	Changes in abdominal circumference (cm)		Baseline and 16 weeks
Secondary	Changes in systolic pressure(SBP)		Baseline and 16 weeks
Secondary	Changes in diastolic pressure (DBP)		Baseline and 16 weeks
Secondary	Change in ß cell function	ß cell function will be assessed by HOMA-ß	Baseline and 16 weeks
Secondary	Change in LDL-c level		Baseline and 16 weeks
Secondary	Change in TG level		Baseline and 16 weeks
Secondary	Change in CHO level		Baseline and 16 weeks
Secondary	Change in liver fiber	liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan	Baseline and 16 weeks
Secondary	Changes in systemic Inflammatory biomarkers	Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).	Baseline and 16 weeks
Secondary	Changes in Oxidative stress markers	Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.	Baseline and 16 weeks
Secondary	Change in depressive symptoms as assessed by Patient Health Questionnaire-9		Baseline and 16 weeks
Secondary	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
Secondary	Changes in time to return to normal menstrual cycle	Changes in time to return to normal menstrual cycle	Baseline and 16 weeks