Clinical trial · Interventional
The University of Michigan PCOS Intervention Using Nutritional Ketosis
NCT03987854CI-TRIAL-00061661completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for women with PCOS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diet and lifestyle program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- complete diet and lifestyle program
- interventionNames
- Behavioral: diet and lifestyle program
Primary outcomes (1)
- measure
- Mean Percent Body Weight Loss
- timeFrame
- 4 months
- description
- Mean percent body weight loss was defined as: (weight at 4 months - baseline weight) / (baseline weight) \*100.
Secondary outcomes (1)
- measure
- HbA1c Change
- timeFrame
- 4 months
- description
- percentage of glycosylated hemoglobin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * We will include women in one PCOS subtype, those having these two symptoms: * Hyperandrogenism - (a) If not on current birth control: hyperandrogenism defined as current elevated total testosterone \>= 50 ng/dL or free androgen index \> 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism (b) if on current birth control: history from the past 10 years of hyperandrogenism defined as past elevated total testosterone \>= 50 ng/dL or free androgen index \> 1.5 (ratio of testosterone/SHBG x 100) or severe acne or hirsutism * oligomenorrhea-anovulation defined as spontaneous intermenstrual periods of ≥ 45 days or a total of ≤ 8 menses per year. Participants must also be: * overweight or obese (BMI 25-50) * be 21-40 years old * have regular access to the internet * be able to engage in light physical activity * willing and able to follow the assigned intervention. Exclusion Criteria: * a non-English speaker * inability to complete baseline measurements * a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy) * pregnant or planning to get pregnant in the next 6 months * type 1 or type 2 diabetes * baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 times normal * baseline renal disease defined as BUN \> 30 mg/dL or serum creatinine \>1.4 mg/dL * baseline uncorrected thyroid disease (TSH \<0.45 mIU/ML or \>4.5 mIU/ML) * breastfeeding or less than 6 months post-partum * planned or history of weight loss surgery * vegan or vegetarian * currently enrolled in a weight loss program or other investigative study that might conflict with this research * taking medications known to cause weight gain or loss * taking hypoglycemic medications other than metformin or medications known to affect metabolism * or patients with other etiologies of anovulation and hyperandrogenism, e.g., Cushing's disease, thyroid dysfunction, elevated prolactin levels, signs of congenital adrenal hyperplasia, organic intra cranial lesion such as a pituitary tumor, or suspected adrenal or ovarian tumor secreting androgens.
References
Publications (1)
- DERIVEDMissel AL, O'Brien AV, Maser H, Kanwal A, Bayandorian H, Martin S, Carrigan P, McNamee R, Daubenmier J, Isaman DJM, Padmanabhan V, Smith YR, Aikens JE, Saslow LR. Impact of an online multicomponent very-low-carbohydrate program in women with polycystic ovary syndrome: a pilot study. F S Rep. 2021 Sep 4;2(4):386-395. doi: 10.1016/j.xfre.2021.08.008. eCollection 2021 Dec. PMID 34934978