Trials / Active Not Recruiting
Active Not RecruitingNCT05452642
The Supporting Understanding of PCOS Education and Research (SUPER) Study
Supporting Understanding of PCOS Education and Research. Official Title: Glycemic Reduction Approaches in Polycystic Ovary Syndrome: a Comparative Effectiveness Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 223 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- Female
- Age
- 21 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
This research will test whether a Dietary Approaches to Stop Hypertension (DASH) or a very low-carbohydrate diet better improves outcomes like blood glucose control and body weight for adults with polycystic ovary syndrome. Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor and a body composition scan (called a dual-energy x-ray absorptiometry or DEXA). Once these enrollment steps are completed and the participants will be randomized to one of two 12-month programs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | DASH diet | Participants in this arm will be taught a DASH diet plus psychological skills to support dietary adherence. |
| BEHAVIORAL | Very low-carbohydrate diet | Participants in this arm will be taught a very low-carbohydrate diet plus psychological skills to support dietary adherence. |
Timeline
- Start date
- 2022-08-15
- Primary completion
- 2026-07-15
- Completion
- 2026-07-15
- First posted
- 2022-07-11
- Last updated
- 2025-12-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05452642. Inclusion in this directory is not an endorsement.