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| Name | Class |
|---|---|
| Jinan Central Hospital | OTHER |
| Civil Aviation General Hospital | OTHER |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
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The goal of this clinical trial is to investigate the effects of a specific dietary program on overweight or obese patients with polycystic ovary syndrome (PCOS) through a multicenter, randomized, controlled, prospective study design.
The main questions it aims to answer are:
Researchers will compare the effects of a specific dietary program versus conventional intervention on clinical remission rates, metabolic outcomes, and anthropometric measures in overweight or obese patients with PCOS.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific dietary intervention | Experimental |
| |
| Conventional intervention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific dietary intervention group | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rate of PCOS | he proportion of participants who achieved regular menstrual cycles after 24 weeks of intervention and maintained regular cycles for at least 3 consecutive months. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Waist circumference | Baseline, Week 12, and Week 24 | |
| Blood pressure | Baseline, Week 12, and Week 24 | |
| Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziye Gong | Contact | 86+13699126297 | gongziye202211@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shan Gao, Doctoral degree | Xuanwu Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | China |
IPD will not be shared due to privacy concerns and the need to protect sensitive participant information. Sharing the data could potentially breach confidentiality agreements and ethical guidelines, as the de-identified data might still be traceable back to participants. Additionally, the research team has not obtained prior consent for data sharing, and sharing IPD would require additional approvals from the ethics committee and participants.
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|
| Conventional intervention | Behavioral | The dietary intervention involves a 20% reduction in total caloric intake, with a balanced distribution of nutrients to ensure adequate intake of essential macronutrients and micronutrients. The intervention will be implemented over a period of 24 weeks. |
|
| Baseline, Week 12, and Week 24 |
| Body fat percentage | Baseline, Week 12, and Week 24 |
| Skeletal muscle mass | Baseline, Week 12, and Week 24 |
| Basal metabolic rate | Baseline, Week 12, and Week 24 |
| Serum anti-Müllerian hormone (AMH) concentration | Serum AMH levels will be measured in fasting serum samples collected at predefined study time points. Outcomes will be reported as circulating AMH concentrations and will be used to assess changes in ovarian reserve-related endocrine function between baseline and post-intervention time points and/or between intervention groups. | Baseline and Week 24 |
| Progesterone | Baseline and Week 24 |
| Fasting plasma glucose | Baseline and Week 24 |
| Fasting insulin | Baseline and Week 24 |
| Total cholesterol | Baseline and Week 24 |
| Low-density lipoprotein cholesterol | Baseline and Week 24 |
| High-density lipoprotein cholesterol | Baseline and Week 24 |
| Triglycerides | Baseline and Week 24 |
| Aspartate aminotransferase | Baseline and Week 24 |
| Alanine aminotransferase | Baseline and Week 24 |
| Dietary intake assessed by food frequency questionnaire (FFQ) | Dietary intake will be assessed using a validated FFQ at predefined study time points. Outcomes will include quantitative estimates of habitual dietary intake, including energy and nutrient intakes, and comparisons of changes in dietary intake between study time points and/or between intervention groups. | Baseline, Week 12, and Week 24 |
| Psychological status assessed by standardized questionnaire | Psychological status will be assessed using a standardized, validated questionnaire administered at predefined study time points. Outcome measures will include questionnaire scores summarized as continuous variables, and changes in psychological status will be compared between baseline and post-intervention time points and/or between intervention groups. | Baseline, Week 12, and Week 24 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | 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 |
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