Clinical trial NCT04580433: Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)
Official title: Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Overweight
Obesity
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2020-10-08
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insulin resistance
timeFrame: 5-week intervention period
measure: Sex hormone-binding globulin (nmol/L)
timeFrame: 5-week intervention period
measure: Body Mass Index (BMI) (kg/m^2)
timeFrame: 5-week intervention period
measure: Waist-to-Hip Ratio (WHR)
timeFrame: 5-week intervention period
measure: Free androgen index (FAI) (%)
timeFrame: 5-week intervention period
measure: Total testosterone (TT) (ng/mL)
timeFrame: 5-week intervention period
measure: Area under the curve (AUC) for insulin
timeFrame: 5-week intervention period
measure: Area under the curve (AUC) for glucose
timeFrame: 5-week intervention period
measure: Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose
timeFrame: 5-week intervention period
measure: Fasting insulin (FINS) (mU/L)
timeFrame: 5-week intervention period
measure: Fasting blood glucose (FBG) (mmol/L)
timeFrame: 5-week intervention period
Secondary outcomes:
measure: Dietary behavior
timeFrame: 5-week intervention period
measure: Time to return to normal menstrual cycle
timeFrame: 5-week intervention period
measure: Insulin-like growth factor 1 (IGF-1) (ng/mL)
timeFrame: 5-week intervention period
measure: Body fat (kg)
timeFrame: 5-week intervention period
measure: Body fat percentage (%)
timeFrame: 5-week intervention period
measure: Visceral fat area (cm^2)
timeFrame: 5-week intervention period
measure: Skeletal muscle content (kg)
timeFrame: 5-week intervention period
measure: High-sensitivity C-reactive protein (hs-CRP) (mg/L)
timeFrame: 5-week intervention period
Other outcomes:
measure: Luteinizing hormone (LH) (mIU/mL)
timeFrame: 5-week intervention period
measure: Follicle-stimulating hormone (FSH) (mIU/mL)
timeFrame: 5-week intervention period
measure: LH/FSH
timeFrame: 5-week intervention period
measure: Uric acid (UA) (umol/L)
timeFrame: 5-week intervention period
measure: Alanine aminotransferase (ALT) (U/L)
timeFrame: 5-week intervention period
measure: Aspartate aminotransferase (AST) (U/L)
timeFrame: 5-week intervention period
measure: Total cholesterol (TC) (mmol/L)
timeFrame: 5-week intervention period
measure: Triglycerides (TG) (mmol/L)
timeFrame: 5-week intervention period
measure: Low density lipoprotein-cholesterol (LDL-C) (mmol/L)
timeFrame: 5-week intervention period
measure: Body weight (kg)
timeFrame: 5-week intervention period
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Bing He, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Chunzhu Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2.