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The Supporting Understanding of PCOS Education and Research (SUPER) Study

NCT05452642 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2025-12-15

No results posted yet for this study

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

  • Polycystic Ovary

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Laura Saslow, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2026-07-15
Completion
2026-07-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452642 on ClinicalTrials.gov