Metabolic SyndromePhase 2COR-PCOSNCT06852365
Combined Oral Contraceptive Pill and Resistance Starch
A Phase 2 study testing wheat dextrin, Oral Contraceptives, Low-Dose and Maltodextrin in people with Metabolic Syndrome and Polycystic Ovary Syndrome, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Metabolic Syndrome, Polycystic Ovary Syndrome
- What is being tested?
- wheat dextrin, Oral Contraceptives, Low-Dose and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2025to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between ages of 18-40 years with BMI greater than or equal to 25 kg/m² to less than or equal to 48 kg/m² diagnosed with PCOS defined by the Rotterdam criteria based on a history of chronic anovulation (8 or fewer periods), androgen excess [defined as total serum testosterone, free testosterone or a FAI greater than or equal to 90% of the upper limit of normal) or hirsutism (Ferriman-Gallwey score greater than 6 for Hispanics/ Black and greater than or equal to 2 for women of Asian descent)] and polycystic ovaries as defined by a pelvic ultrasound (20 or more follicles or ovarian vol greater than 10cm3) or elevated AMH.
- For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation.
- Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS.
- Subjects should be willing to avoid pregnancy for the entire duration of the study.
Who cannot join
- 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.
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- 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:
- Type 1 or 2 diabetes
- liver disease or dysfunctional liver (AST/ALT greater than 2x normal or a total bilirubin greater than 2.5 mg/dL)
- renal disease (BUN greater than 30 mg/dL or serum creatinine greater than 1.4 mg/dL)
- severe anemia (hemoglobin less than 10 mg/dL)
- alcohol abuse
- poorly controlled hypertension
- TG greater than 250 mg/dl
- chronic inflammatory conditions such as psoriasis
- history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher)
- history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Anuja Dokras, MD PhD
Andrea Morley, 215-615-4202, andrea.morley@pennmedicine.upenn.edu
About this study
Official title: Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)
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.
- Conditions
- Metabolic Syndrome, Polycystic Ovary Syndrome
- Being tested
- wheat dextrin, Oral Contraceptives, Low-Dose, Maltodextrin
- Medical subject headings
- Metabolic Syndrome, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheat dextrinDietary supplement
Also called Benefiber
participants will take 15 grams per day for 12 weeks
Oral Contraceptives, Low-DoseDrug
20 micrograms ethinyl estradiol and desogestrel 0.15mg
MaltodextrinDietary supplement
participants will take 15 grams per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Resistant Starch | Active comparator | wheat dextrin Receives: Dietary Supplement: wheat dextrin; Drug: Oral Contraceptives, Low-Dose |
| Placebo | Placebo comparator | maltodextrin Receives: Drug: Oral Contraceptives, Low-Dose; Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-C measure
Measured: Baseline and 12 weeks
Change in fasting glucose measure
Measured: Baseline and 12 weeks
Change in systolic blood pressure
Measured: Baseline and 12 weeks
Change in diastolic blood pressure
Measured: Baseline and 12 weeks
Change in BMI
Measured: Baseline and 12 weeks
Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)
Measured: Baseline and 12 weeks
Change in Single Chain Fatty Acids (SCFA)
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Jun 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Anuja Dokras, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852365
- Sponsor's protocol ID
- 856886
- Other IDs
- 1R01HL173772-01
- Acronym
- COR-PCOS
- Status last verified
- May 2026
- First submitted
- 24 Feb 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)
- ClinicalTrials.gov ID
- NCT06852365
- Acronym / sponsor ID
- COR-PCOS / 856886
- Conditions
- Metabolic Syndrome, Polycystic Ovary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant Starch | Active comparator | Dietary Supplement: wheat dextrin, Drug: Oral Contraceptives, Low-Dosewheat dextrin |
| Placebo | Placebo comparator | Drug: Oral Contraceptives, Low-Dose, Dietary Supplement: Maltodextrinmaltodextrin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between ages of 18-40 years with BMI greater than or equal to 25 kg/m² to less than or equal to 48 kg/m² diagnosed with PCOS defined by the Rotterdam criteria based on a history of chronic anovulation (8 or fewer periods), androgen excess [defined as total serum testosterone, free testosterone or a FAI greater than or equal to 90% of the upper limit of normal) or hirsutism (Ferriman-Gallwey score greater than 6 for Hispanics/ Black and greater than or equal to 2 for women of Asian descent)] and polycystic ovaries as defined by a pelvic ultrasound (20 or more follicles or ovarian vol greater than 10cm3) or elevated AMH.
- For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation.
- Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS.
- Subjects should be willing to avoid pregnancy for the entire duration of the study.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wheat dextrinAlso: Benefiberparticipants will take 15 grams per day for 12 weeks | Dietary supplement | Resistant Starch |
| Oral Contraceptives, Low-Dose20 micrograms ethinyl estradiol and desogestrel 0.15mg | Drug | Placebo, Resistant Starch |
| Maltodextrinparticipants will take 15 grams per day for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change in LDL-C measure
Time frame: Baseline and 12 weeks
Change in fasting glucose measure
Time frame: Baseline and 12 weeks
Change in systolic blood pressure
Time frame: Baseline and 12 weeks
Change in diastolic blood pressure
Time frame: Baseline and 12 weeks
Change in BMI
Time frame: Baseline and 12 weeks
Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)
Time frame: Baseline and 12 weeks
Change in Single Chain Fatty Acids (SCFA)
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing wheat dextrin, Oral Contraceptives, Low-Dose and Maltodextrin in people with Metabolic Syndrome and Polycystic Ovary Syndrome, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anuja Dokras, MD PhD (215-615-0085, adokras@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL-C measure (time frame: Baseline and 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.