Polycystic Ovary Syndrome, Overweight, Obesity
Conditions
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.
Interventions
BEHAVIORALTime-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.
Sponsors
National Natural Science Foundation of China
Chunzhu Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | 5-week intervention period | Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR) |
| Fasting blood glucose (FBG) (mmol/L) | 5-week intervention period | — |
| Fasting insulin (FINS) (mU/L) | 5-week intervention period | — |
| Waist-to-Hip Ratio (WHR) | 5-week intervention period | Waist and hip will be combined to report WHR |
| Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose | 5-week intervention period | Glucose tolerance test will be conducted |
| Area under the curve (AUC) for glucose | 5-week intervention period | Glucose tolerance test will be conducted |
| Area under the curve (AUC) for insulin | 5-week intervention period | Insulin release test will be conducted |
| Body Mass Index (BMI) (kg/m^2) | 5-week intervention period | Weight (kg) and height (m) will be combined to report BMI |
| Total testosterone (TT) (ng/mL) | 5-week intervention period | — |
| Free androgen index (FAI) (%) | 5-week intervention period | — |
| Sex hormone-binding globulin (nmol/L) | 5-week intervention period | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat percentage (%) | 5-week intervention period | Measured by InBody, a body composition analyzer |
| Dietary behavior | 5-week intervention period | Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire |
| Time to return to normal menstrual cycle | 5-week intervention period | — |
| Insulin-like growth factor 1 (IGF-1) (ng/mL) | 5-week intervention period | — |
| Body fat (kg) | 5-week intervention period | Measured by InBody, a body composition analyzer |
| Visceral fat area (cm^2) | 5-week intervention period | Measured by InBody, a body composition analyzer |
| Skeletal muscle content (kg) | 5-week intervention period | Measured by InBody, a body composition analyzer |
| High-sensitivity C-reactive protein (hs-CRP) (mg/L) | 5-week intervention period | A kind of inflammatory biomarker |
Other
| Measure | Time frame |
|---|---|
| Luteinizing hormone (LH) (mIU/mL) | 5-week intervention period |
| Body weight (kg) | 5-week intervention period |
| Low density lipoprotein-cholesterol (LDL-C) (mmol/L) | 5-week intervention period |
| Triglycerides (TG) (mmol/L) | 5-week intervention period |
| Total cholesterol (TC) (mmol/L) | 5-week intervention period |
| Aspartate aminotransferase (AST) (U/L) | 5-week intervention period |
| Alanine aminotransferase (ALT) (U/L) | 5-week intervention period |
| Uric acid (UA) (umol/L) | 5-week intervention period |
| LH/FSH | 5-week intervention period |
| Follicle-stimulating hormone (FSH) (mIU/mL) | 5-week intervention period |
Countries
China
Outcome results
None listed