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

Not Applicable

Active, not recruiting

• Conditions: Polycystic Ovary
• Interventions: Behavioral: Very low-carbohydrate diet; Behavioral: DASH diet

• Registration Number: NCT05452642
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Study Start: 2022-08-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 214

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very low-carbohydrate diet	Very low-carbohydrate diet	12-month very low-carbohydrate diet intervention with psychological support
DASH diet	DASH diet	12-month DASH diet intervention with psychological support

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	0 to 12 months	percentage of glycosylated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Change in percent body weight loss	0-12 months	percent change
Change in glycemic variability	0 to 12 months	This will be measured with an Abbott Libre Pro continuous glucose monitoring device on participants' upper arm and the information on the sensor is blinded to participants.; The monitoring device will record participants' glucose levels in the interstitial fluid by a glucose oxidase method every 15 minutes, continuously for 14 days at each time point.; The glucose variability and the proportion of time spent in the euglycemic (3-7.8 millimoles per litre (mmol/l)) and hyperglycemic (≥ 11.1 mmol/l for at least 15 minutes) states, following previous standards for interstitial glucose concentrations.
Change in percent body fat on DEXA	0 to 12 months	This will be measured by dual-energy X-ray absorptiometry scan
Change in HbA1c	0 to 4 months	percentage of glycosylated hemoglobin

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States