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Polycystic OvarySUPERNCT05452642

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

A study testing DASH diet and Very low-carbohydrate diet in people with Polycystic Ovary, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 45 years, women only
Conditions the study is for
Polycystic Ovary
What is being tested?
DASH diet and Very low-carbohydrate diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
1 siteUnited States
Study dates
15 Aug 2022to 13 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
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  • 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
  • Ability to engage in light physical activity
  • Willingness to be randomized to either dietary approach
  • Measured HbA1c at baseline of 5.3%-9.0%

Who cannot join

  • 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
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  • 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
  • difficulty chewing or swallowing
  • no influence over what foods are purchased, prepared, and/or served or inability to follow dietary advice due to lack of money or other resources
  • above weight limit (500 lbs) for DEXA
  • self-report of alcohol or substance use disorder within the past 5 years, including current at-risk drinking based on an AUDIT score of 15 or higher (but those who score a 15 or higher and have this criterion as their only reason for ineligibility may be assessed by a clinical psychologist for alcohol use disorder and if deemed to not have such a disorder would be eligible for the trial)
  • Safety
  • Renal disease: BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL in our screening blood tests or history of kidney stones
  • untreated eating disorder or unstable serious mental illness (such as depression (score of 20 or greater on the PHQ8), bipolar or schizophrenia with psychosis)
  • use of warfarin
  • chronic kidney disease, stage 4 or higher
  • Any other concerning values in baseline labs (we will plan to send the participant to their PCP and allow the participant to return for later enrollment if labs are no longer concerning) Examples:
  • triglycerides of 600 mg/dL or higher
  • baseline uncorrected thyroid disease: TSH < .45 mIU/ML or > 4.5 mIU/ML
  • potassium: any abnormal value
  • baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times normal
  • any condition for which the study team deems participation to be unsafe or inappropriate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Supporting Understanding of PCOS Education and Research. Official Title: Glycemic Reduction Approaches in Polycystic Ovary Syndrome: a Comparative Effectiveness Study

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.

Being tested
DASH diet, Very low-carbohydrate diet
Keywords
Very low carbohydrate diet, Dietary approaches to stop hypertension (DASH) diet, Nutrition therapy
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DASH dietBehavioural

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

  • Very low-carbohydrate dietBehavioural

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

Study groups in NCT05452642
Study groupRoleWhat they receive
DASH dietActive comparator12-month DASH diet intervention with psychological support
Receives: Behavioral: DASH diet
Very low-carbohydrate dietExperimental12-month very low-carbohydrate diet intervention with psychological support
Receives: Behavioral: Very low-carbohydrate diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    percentage of glycosylated hemoglobin

    Measured: 0 to 12 months

Secondary outcomes (4)

  1. Change in percent body weight loss

    percent change

    Measured: 0-12 months

  2. Change in glycemic variability

    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.

    Measured: 0 to 12 months

  3. Change in percent body fat on DEXA

    This will be measured by dual-energy X-ray absorptiometry scan

    Measured: 0 to 12 months

  4. Change in HbA1c

    percentage of glycosylated hemoglobin

    Measured: 0 to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start15 Aug 2022
  3. Primary completion13 Jun 2026
  4. Study completion13 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452642
Sponsor's protocol ID
HUM00210749
Other IDs
1R01DK128205-01A1
Acronym
SUPER
Status last verified
Aug 2026
First submitted
6 Jul 2022
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39516828

Questions about this trial

What is this clinical trial studying?

A study testing DASH diet and Very low-carbohydrate diet in people with Polycystic Ovary, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 0 to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05452642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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