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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL173772-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Starch | Active Comparator | wheat dextrin |
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| Placebo | Placebo Comparator | maltodextrin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wheat dextrin | Dietary Supplement | participants will take 15 grams per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL-C measure | Baseline and 12 weeks | |
| Change in fasting glucose measure | Baseline and 12 weeks | |
| Change in systolic blood pressure | Baseline and 12 weeks | |
| Change in diastolic blood pressure | Baseline and 12 weeks | |
| Change in BMI | Baseline and 12 weeks | |
| Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR) | Baseline and 12 weeks | |
| Change in Single Chain Fatty Acids (SCFA) | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.
Subjects with late onset adrenal hyperplasia
Subjects with history of bariatric surgery
Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.
Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications).
History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded.
Subjects could not have taken antibiotics for at least 3 months prior to randomization visit.
Subjects with greater than 20 g/day of dietary fiber intake based on pre-screening ASA-24 survey will be excluded.
Subjects with medical conditions that are contraindications to use of OCP and other medical conditions such as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anuja Dokras, MD PhD | Contact | 215-615-0085 | adokras@pennmedicine.upenn.edu | |
| Andrea Morley | Contact | 215-615-4202 | andrea.morley@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| Oral Contraceptives, Low-Dose | Drug | 20 micrograms ethinyl estradiol and desogestrel 0.15mg |
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| Maltodextrin | Dietary Supplement | participants will take 15 grams per day for 12 weeks |
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| D009750 |
| Nutritional and Metabolic Diseases |
| 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 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |