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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRF | Experimental | Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction. |
|
| Usual care | Active Comparator | Participants in this group will receive a general lifestyle counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Feeding | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight (Kilograms) | Changes in body weight (Kilograms) | Baseline and 16 weeks |
| Change in insulin resistance | Insulin resistance will be assessed by HOMA-IR | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI | Baseline and 16 weeks | |
| Changes in waist circumference (cm) | Baseline and 16 weeks | |
| Changes in Waist-to-Hip Ratio(WHR) |
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Inclusion Criteria:
Exclusion Criteria:
Only women have the PCOS.
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| Name | Affiliation | Role |
|---|---|---|
| Changqin Liu, MD | The first afilliated hospital of Xiamen university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first afilliated hospital of Xiamen university | Xiamen | Fujian | 361003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512717 | Derived | Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D050177 | Overweight |
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Usual care | Behavioral | Participants receive a general lifestyle counseling. |
|
| Baseline and 16 weeks |
| Changes in systolic pressure(SBP) | Baseline and 16 weeks |
| Changes in diastolic pressure (DBP) | Baseline and 16 weeks |
| Change in Body fat percent | Baseline and 16 weeks |
| Change in Fat mass | Baseline and 16 weeks |
| Change in Skeletal muscle mass | Baseline and 16 weeks |
| Change in CHO level | Baseline and 16 weeks |
| Change in TG level | Baseline and 16 weeks |
| Change in HDL level | Baseline and 16 weeks |
| Change in LDL-c level | Baseline and 16 weeks |
| Change in Fasting Blood Glucose (FBG) level | Baseline and 16 weeks |
| Change in ALT level | Baseline and 16 weeks |
| Change in AST level | Baseline and 16 weeks |
| Change in GGT level | Baseline and 16 weeks |
| Change in Testosterone level | Baseline and 16 weeks |
| Change in Sex hormone binding globulin (SHBG) level | baseline and 16 weeks |
| Change in Free androgen index (FAI) | Basline and 16 weeks |
| Change in Ferriman-Gallway score (F-G score:) | Baseline and 16 weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |