Could a fiber supplement improve PCOS heart risks?
NCT ID NCT06852365
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a daily fiber supplement (resistant starch, like Benefiber) can improve heart health markers and gut bacteria in women with polycystic ovary syndrome (PCOS). One hundred women will take either the fiber or a placebo for 12 weeks, alongside standard birth control pills. Researchers will measure changes in cholesterol, blood sugar, blood pressure, and gut microbes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- resistant starch (wheat dextrin, also known as Benefiber)
- What this could lead to
- If it works, this could point toward a simple dietary supplement to improve heart health and gut balance in women with PCOS.
- What could go wrong
- This is an early phase 2 trial with only 100 participants, so results may not apply to everyone. The supplement may show no benefit over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Subjects should be willing to avoid pregnancy for the entire duration of the study. Exclusion Criteria: 1. Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause. 2. Subjects with late onset adrenal hyperplasia 3. Subjects with history of bariatric surgery 4. Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies. 5. Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications). 6. History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded. 7. Subjects could not have taken antibiotics for at least 3 months prior to randomization visit. 8. Subjects with greater than 20 g/day of dietary fiber intake based on pre-screening ASA-24 survey will be excluded. 9. Subjects with medical conditions that are contraindications to use of OCP and other medical conditions such as: 1. Type 1 or 2 diabetes 2. liver disease or dysfunctional liver (AST/ALT greater than 2x normal or a total bilirubin greater than 2.5 mg/dL) 3. renal disease (BUN greater than 30 mg/dL or serum creatinine greater than 1.4 mg/dL) 4. severe anemia (hemoglobin less than 10 mg/dL) 5. alcohol abuse 6. poorly controlled hypertension 7. TG greater than 250 mg/dl 8. chronic inflammatory conditions such as psoriasis 9. history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher) 10. history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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