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Can a diet tame PCOS? study pits DASH against Low-Carb

NCT ID NCT05452642

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests whether a DASH diet or a very low-carbohydrate diet is better at improving blood sugar control and body weight in adults with polycystic ovary syndrome (PCOS). 223 participants will follow one of the two diets for 12 months, with support from psychological skills training. The goal is to find which diet works best for managing PCOS symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DASH diet or very low-carbohydrate diet
What this could lead to
If successful, this study could show that one of these diets is better for managing blood sugar and weight in people with PCOS, offering a practical lifestyle approach.
What could go wrong
This is a behavioral study, not a drug trial, so results depend on participants sticking to the diet. It may not work for everyone, and long-term benefits are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

223 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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 * Ability to engage in light physical activity * Willingness to be randomized to either dietary approach * Measured HbA1c at baseline of 5.3%-9.0% Exclusion criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.