An interventional study of Time-Restricted Feeding in Polycystic Ovary Syndrome, Overweight and Obesity, sponsored by Chunzhu Li. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Chunzhu Li · Not applicable, Interventional, and Treatment
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.
This study's enrollment of 18 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →This is the only study on the registry with Chunzhu Li as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Participants will receive 16:8 TRF.
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.
Insulin resistance
Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)
Time frame: 5-week intervention period
Sex hormone-binding globulin (nmol/L)
Time frame: 5-week intervention period
Body Mass Index (BMI) (kg/m^2)
Weight (kg) and height (m) will be combined to report BMI
Time frame: 5-week intervention period
Waist-to-Hip Ratio (WHR)
Waist and hip will be combined to report WHR
Time frame: 5-week intervention period
Free androgen index (FAI) (%)
Time frame: 5-week intervention period
Total testosterone (TT) (ng/mL)
Time frame: 5-week intervention period
Area under the curve (AUC) for insulin
Insulin release test will be conducted
Time frame: 5-week intervention period
Area under the curve (AUC) for glucose
Glucose tolerance test will be conducted
Time frame: 5-week intervention period
Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose
Glucose tolerance test will be conducted
Time frame: 5-week intervention period
Fasting insulin (FINS) (mU/L)
Time frame: 5-week intervention period
Fasting blood glucose (FBG) (mmol/L)
Time frame: 5-week intervention period
Dietary behavior
Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire
Time frame: 5-week intervention period
Time to return to normal menstrual cycle
Time frame: 5-week intervention period
Insulin-like growth factor 1 (IGF-1) (ng/mL)
Time frame: 5-week intervention period
Body fat (kg)
Measured by InBody, a body composition analyzer
Time frame: 5-week intervention period
Body fat percentage (%)
Measured by InBody, a body composition analyzer
Time frame: 5-week intervention period
Visceral fat area (cm^2)
Measured by InBody, a body composition analyzer
Time frame: 5-week intervention period
Skeletal muscle content (kg)
Measured by InBody, a body composition analyzer
Time frame: 5-week intervention period
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
A kind of inflammatory biomarker
Time frame: 5-week intervention period
Luteinizing hormone (LH) (mIU/mL)
Time frame: 5-week intervention period
Follicle-stimulating hormone (FSH) (mIU/mL)
Time frame: 5-week intervention period
LH/FSH
Time frame: 5-week intervention period
Uric acid (UA) (umol/L)
Time frame: 5-week intervention period
Alanine aminotransferase (ALT) (U/L)
Time frame: 5-week intervention period
Aspartate aminotransferase (AST) (U/L)
Time frame: 5-week intervention period
Total cholesterol (TC) (mmol/L)
Time frame: 5-week intervention period
Triglycerides (TG) (mmol/L)
Time frame: 5-week intervention period
Low density lipoprotein-cholesterol (LDL-C) (mmol/L)
Time frame: 5-week intervention period
Body weight (kg)
Time frame: 5-week intervention period
Plan to share: No
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