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Protein power: could a High-Protein diet tame PCOS metabolic risks?

NCT ID NCT07158723

Disease control Sponsor: University of Arkansas, Fayetteville Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a higher protein diet (30% of calories from protein) can improve metabolic health in women with polycystic ovary syndrome (PCOS). Sixty women with PCOS will follow a calorie-restricted diet for 16 weeks, with some eating more protein. Researchers will measure changes in lean body mass, fat mass, and sleep quality.

What this could mean

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

Active substance
higher protein dietary pattern
What this could lead to
If it works, this could point toward a simple dietary approach to help manage metabolic complications like insulin resistance and heart disease risk in women with PCOS.
What could go wrong
This is a small, early-stage trial (60 participants) testing a dietary change, not a drug. Results may not apply to all women with PCOS, and the effect may be modest or hard to sustain long-term.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Females ages 18-50 years * Confirmed diagnosis of PCOS * Body mass index (BMI) between 18.5 and 35 kg/m2 * Stable body weight for at least 3 months (+ 5 pounds) * Willingness to consume both plant- and animal-based protein meals Exclusion Criteria: * Smoking or use of nicotine products * Smoking, vaping, and/or use of marijuana products * More than 4 alcoholic beverages per week * Food allergies or dietary restrictions incompatible with test meals * Diagnosed diabetes (type 1 or 2) or other preexisting chronic disease(s). * Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.) * Consumption of more than 0.8 g/protein/kg body weight * Underweight * Taking nutritional supplements

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

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

Polycystic ovary syndrome (PCOS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Human Nutrition

    RECRUITING

    Fayetteville, Arkansas, 72704, United States

  • Center for Human Nutrition

    RECRUITING

    Fayetteville, Arkansas, 72704, United States

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