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

NCT05452642 | Active Not Recruiting DMC

• 2 other identifiers: HUM002107491R01DK128205-01A1
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary

Keywords

Very low carbohydrate diet; Dietary approaches to stop hypertension (DASH) diet; Nutrition therapy

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  percentage of glycosylated hemoglobin

  0 to 12 months

Secondary Outcomes (4)

• Change in percent body weight loss

  0-12 months

• Change in glycemic variability

  0 to 12 months

• Change in percent body fat on DEXA

  0 to 12 months

• Change in HbA1c

  0 to 4 months

Study Arms (2)

DASH diet

ACTIVE COMPARATOR

12-month DASH diet intervention with psychological support

Behavioral: DASH diet

Very low-carbohydrate diet

EXPERIMENTAL

12-month very low-carbohydrate diet intervention with psychological support

Behavioral: Very low-carbohydrate diet

Interventions

DASH diet BEHAVIORAL

Participants in this arm will be taught a DASH diet plus psychological skills to support dietary adherence.

DASH diet

Very low-carbohydrate diet BEHAVIORAL

Participants in this arm will be taught a very low-carbohydrate diet plus psychological skills to support dietary adherence.

Very low-carbohydrate diet

Eligibility Criteria

• Age: 21 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have the following criteria:
• oligomenorrhea-anovulation
• spontaneous intermenstrual periods (if not on hormonal birth control or birth control that alters menstrual cycle timing) of \< 21 days or \> 35 days or a total of 8 or fewer menses per year
• if on hormonal birth control or birth control that alters menstrual cycle timing, a history of irregular periods
• and hyperandrogenism
• If not on hormonal birth control or birth control that alters menstrual cycle timing: Total testosterone ≥ 35 ng/dL OR free testosterone \> 4.0 pg/ml OR free androgen index \> 1.5 OR in-person scoring for hirsutism, based on the modified Ferriman-Gallwey score, if attending an in-person assessment or based on the self-assessment (if not attending an in-person assessment) with a score of ≥ 4 considered hirsutism;
• If on hormonal birth control or birth control that alters menstrual cycle timing: Tests within the past 10 years showing the above or study team's in-person assessment of hirsutism as above.
• If no medical records to confirm (most recent test from within the last 10 years in range), tests for diagnosis will be ordered:
• total testosterone \< 100 ng/dL,
• dehydroepiandrosterone sulfate (DHEAS) \< 600 μg/dL,
• fasting 17-hydroxyprogesterone (17-OHP) level \< 2.0 ng/mL,
• prolactin \< 25 ng/ml),
• follicle-stimulating hormone (FSH) levels \< 20 mIU/mL
• BMI 25-50 kg/m2 or 23-50 kg/m2 for Asians
• Access to internet

You may not qualify if:

• Primary
• Patients with non-PCOS etiologies of anovulation and hyperandrogenism (Cushing's disease, thyroid dysfunction, elevated prolactin levels, signs of a congenital adrenal hyperplasia organic intracranial lesion like a pituitary tumor, or suspected adrenal or ovarian tumor secreting androgens)
• Menopause or removal of the ovaries
• history of type 1 diabetes
• use of medications prescribed for weight loss or psychostimulants known to affect weight
• participation in another weight loss program or intervention
• use of glucose lowering medications other than metformin or medications known to affect metabolism, such as chronic oral corticosteroids
• pregnant or planning to become pregnant during the intervention period
• Breastfeeding or less than 6 months postpartum
• previous bariatric surgery or planning to have bariatric surgery during the study period
• Self-reported blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, and polycythemia
• Ability
• inability to read, write, or speak English
• inability to provide informed consent
• adherence to a vegan or vegetarian diet

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Greenwell S, Jones A, Smith YR, Marriott D, Aikens JE, Padmanabhan V, Saslow LR. Protocol for a randomized comparative effectiveness trial comparing a very low-carbohydrate diet to DASH diet for polycystic ovary syndrome: the SUPER (Supporting Understanding of PCOS Education and Research) trial. Trials. 2024 Nov 9;25(1):750. doi: 10.1186/s13063-024-08583-y.

  PMID: 39516828 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Laura Saslow, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment and data analysis will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)