Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)

Obesity Clinical Trial

— PCOS  

Official title:

Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580433
• Other study ID #: 2020161820
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 16, 2021

Study information

• Verified date: April 2021
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intermittent fasting is an increasingly popular diet pattern of alternating eating and dieting.One particular form of intermittent fasting is the so-called time-restricted feeding (TRF). TRF allows for ad libitum feeding within a large window of time each day, and does not require any calorie counting. There is growing evidence that it can lose weight, reduce insulin resistance and improve cardiometabolic health. Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disease affecting women of childbearing age. PCOS shows anovulation or oligoovulation, hyperandrogenemia and ovarian polycystic changes. Insulin resistance and obesity are common features of PCOS. Whether the TRF impacts women with PCOS is still unknown due to the paucity of data in this area. To explore the effects of TRF on the endocrine and metabolic profile in overweight women with PCOS, a 6-week single-arm trial, divided into 2 consecutive periods: (1) 1-week baseline period; and (2) 5-week TRF period, will be implemented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 16, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Age = 18 years; BMI=24kg/m2; Anovulation; Rott-PCOS.

Exclusion Criteria:

Taking weight loss or regulate hormone secretion medications in recent 6 months; The body weight fluctuated more than 5% in the past 3 months; Preparation for pregnancy, having been in pregnancy or lactation; Perimenopausal; Night-shift workers; Fasting more than 16 hours a day; Hypotension; Patients with other diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, severe serious cardiovascular, gastrointestinal, kidney or liver diseases); Alcohol intake more than 100g per week; Smoking within 3 months; Engaging in high-intensity exercise.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Behavioral:
• Time-Restricted Feeding
The trial consists of a 1-week baseline weight stabilization period followed by a 5-week TRF intervention period. Participants will be instructed to eat freely from 8 a.m. to 4 p.m. daily and fast from 4 p.m. to 8 a.m. the next day.

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Chunzhu Li	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Luteinizing hormone (LH) (mIU/mL)		5-week intervention period
Other	Follicle-stimulating hormone (FSH) (mIU/mL)		5-week intervention period
Other	LH/FSH		5-week intervention period
Other	Uric acid (UA) (umol/L)		5-week intervention period
Other	Alanine aminotransferase (ALT) (U/L)		5-week intervention period
Other	Aspartate aminotransferase (AST) (U/L)		5-week intervention period
Other	Total cholesterol (TC) (mmol/L)		5-week intervention period
Other	Triglycerides (TG) (mmol/L)		5-week intervention period
Other	Low density lipoprotein-cholesterol (LDL-C) (mmol/L)		5-week intervention period
Other	Body weight (kg)		5-week intervention period
Primary	Insulin resistance	Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)	5-week intervention period
Primary	Sex hormone-binding globulin (nmol/L)		5-week intervention period
Primary	Body Mass Index (BMI) (kg/m^2)	Weight (kg) and height (m) will be combined to report BMI	5-week intervention period
Primary	Waist-to-Hip Ratio (WHR)	Waist and hip will be combined to report WHR	5-week intervention period
Primary	Free androgen index (FAI) (%)		5-week intervention period
Primary	Total testosterone (TT) (ng/mL)		5-week intervention period
Primary	Area under the curve (AUC) for insulin	Insulin release test will be conducted	5-week intervention period
Primary	Area under the curve (AUC) for glucose	Glucose tolerance test will be conducted	5-week intervention period
Primary	Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose	Glucose tolerance test will be conducted	5-week intervention period
Primary	Fasting insulin (FINS) (mU/L)		5-week intervention period
Primary	Fasting blood glucose (FBG) (mmol/L)		5-week intervention period
Secondary	Dietary behavior	Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire	5-week intervention period
Secondary	Time to return to normal menstrual cycle		5-week intervention period
Secondary	Insulin-like growth factor 1 (IGF-1) (ng/mL)		5-week intervention period
Secondary	Body fat (kg)	Measured by InBody, a body composition analyzer	5-week intervention period
Secondary	Body fat percentage (%)	Measured by InBody, a body composition analyzer	5-week intervention period
Secondary	Visceral fat area (cm^2)	Measured by InBody, a body composition analyzer	5-week intervention period
Secondary	Skeletal muscle content (kg)	Measured by InBody, a body composition analyzer	5-week intervention period
Secondary	High-sensitivity C-reactive protein (hs-CRP) (mg/L)	A kind of inflammatory biomarker	5-week intervention period