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Polycystic Ovary Syndrome (PCOS)NCT07158723

Protein and Polycystic Ovary Syndrome (PCOS)

A study testing Higher protein dietary pattern and Calorie restriction in people with Polycystic Ovary Syndrome (PCOS), run by University of Arkansas, Fayetteville at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome (PCOS)
What is being tested?
Higher protein dietary pattern and Calorie restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
1 Aug 2025to 3 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.)
Show all 9Show fewer
  • Consumption of more than 0.8 g/protein/kg body weight
  • Underweight
  • Taking nutritional supplements

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • Center for Human Nutrition

    Fayetteville, Arkansas, 72704

    Jamie Baum, PhD, 479-575-4474, baum@uark.edu

    Sydney Boudrey, MS, RDN, seboudre@uark.edu

    Recruiting
  • Center for Human Nutrition

    Fayetteville, Arkansas, 72704

    Jamie Baum, PhD, 479-575-4474, baum@uark.edu

    Sydney Boudrey, MS, RDN, seboudre@uark.edu

    Recruiting

Other trials in United States

About this study

Official title: Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)

Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood pressure, sleep apnea, anxiety, depression, and stroke) especially if they are overweight. Lifestyle modifications, including dietary changes and regular physical activity, may alleviate metabolic dysfunction in women with PCOS and are often the first line of management for patients with PCOS. Several studies have identified protein as a key nutrient for regulation of energy balance, maintenance of skeletal muscle mass, and improving cardiometabolic health across the lifespan. However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well-defined and mechanisms for these effects have not been identified.

There is an evident need for well-designed, randomized controlled trials evaluating the efficacy of increased protein intake in women with PCOS on markers of cardiometabolic health. Preliminary data from collaborative projects with the investigators on this proposal suggest that increasing protein in the diet has the potential to improve markers of cardiometabolic health, potentially through improvements in body composition and/or changes in cortisol, energy metabolism, inflammation, and neurological regulators

Being tested
Higher protein dietary pattern, Calorie restriction
Keywords
PCOS, polycystic ovary syndrome, protein, women, wellbeing, metabolism
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.

  • Higher protein dietary patternOther

    Follow energy-restricted (10% calorie reduction), higher protein dietary pattern (1.6 g protein/kg body weight)

  • Calorie restrictionOther

    Follow energy-restricted (10% calorie reduction) dietary pattern for 16 weeks. No restrictions on macronutrient content.

Study groups in NCT07158723
Study groupRoleWhat they receive
Calorie restricted controlActive comparatorNot described
Receives: Other: Calorie restriction
Control and ProteinActive comparatorNot described
Receives: Other: Higher protein dietary pattern
Calorie restricted PCOSActive comparatorNot described
Receives: Other: Calorie restriction
PCOS ProteinActive comparatorNot described
Receives: Other: Higher protein dietary pattern

What is being measured

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

  1. Lean body mass

    Lean body mass will be measured using dual x-ray absorptiometry.

    Measured: 0 and 16 weeks.

Secondary outcomes (8)
  1. Body fat mass

    Total body fat and body fat distribution will measured using dual x-ray absorptiometry.

    Measured: 0 and 16 weeks

  2. Sleep Duration

    Sleep quality and duration will be assessed objectively via an ActiGraph triaxial wrist accelerometer GT3X+, ActiGraph, LLC, Pensacola, FL, USA), a validated method of sleep assessment. Each participant will wear an ActiGraph monitor on the non-dominant wrist for 24-hour per day for seven days (except when bathing or involved in water activities) prior to the start of the intervention, 8-, and 16-weeks. Actigraphs will be fitted securely on each participants wrist. Participants will receive sleep diaries to define "time in bed" and "time out of bed". Researchers will use the indicated "start" and "end" points to define a sleep region to be analyzed within the ActiGraph software. Sleep outcomes will be calculated based on epoch-to-epoch sleep/wake algorithms within the defined sleep period. Data were processed by using the ActiLife Version 6.9.2 software (Pensacola, FL, USA) and sleep will be scored via the Cole-Kripke algorithm.

    Measured: Sleep will be measured every 8 weeks (0, 8, and 16 weeks)

  3. Mood

    The Profile of Mood States (POMS) questionnaire consists of 65 questions containing a one-word adjective of mood to measure and identify six affective states. The six identifiable mood/affective states are tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue/-inertia, and confusion-bewilderment. Participants will be instructed to define their mood on a 5-point Likert scale ranging from 0 to 4. The numbers refer to the following descriptive phrases: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a bit, 4 = Extremely. To obtain the score for reach identifiable mood/affective state subscale, the sum of the responses for each adjective is calculated. The subscale scores range from 0 up to 36, 60, 48, 32, 28, and 28 for tension-anxiety depression-dejection, anger-hostility, vigor-activity, fatigue/-inertia, and confusion-bewilderment respectively. Higher subscale scores for all affect states, but the vigor domain represent poorer mood.

    Measured: Every 4 weeks (0, 4, 8, 12, 16 weeks)

  4. Quality of Life perception

    Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The instrument consists of 36 items grouped into eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Items will be scored using standard Likert-type response scales and coded according to established procedures. Raw scores for each domain were summed and linearly transformed to a 0-100 scale, with higher scores indicating better health status.

    Measured: Every 4 weeks (0, 4, 8, 12, and 16 weeks)

  5. Energy expenditure

    Indirect calorimetry will be used to measure energy expenditure

    Measured: Every 4 weeks (0, 4, 8, 12 and 16 weeks)

  6. Plasma amino acid concentrations

    Plasma amino acids will be measured using UPL.

    Measured: Every 4 weeks (0, 4, 8, 12 and 16 weeks).

  7. Inflammatory biomarkers

    Inflammatory status will be evaluated using established circulating biomarkers that reflect systemic, low-grade inflammation. The primary analytes include high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α). hs-CRP is an acute-phase reactant produced by the liver and is widely used as a sensitive indicator of chronic inflammation and cardiovascular risk. IL-6 is a pro-inflammatory cytokine that plays a central role in immune regulation and metabolic function, while TNF-α is a key mediator of systemic inflammation and tissue catabolism. Together, these biomarkers provide complementary information on both acute-phase and cytokine-mediated pathways of inflammation and are commonly used in clinical and epidemiological studies to quantify inflammatory burden.

    Measured: Every 4 weeks (0, 4, 8, 12, and 16 weeks).

  8. Subjective Sleep Measurements

    Subjective measure of sleep quality will be assessed via the Pittsburgh Sleep Quality Index (PSQI) . The 19-item PSQI questionnaire addresses seven components of subjective sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global sleeping score (GSS) with a range of 0 to 21. Higher scores indicate worse sleep quality. A compiled global score of the seven scored components distinguishes good sleepers (≤ 5) from poor sleepers (>5). According to a test-retest reliability and validity experiment, as a marker for sleep disturbances, a PSQI GSS > 5 has a sensitivity of 98.7 and specificity of 84.4.

    Measured: Subjective sleep will be measured at 0, 4, 8, 12, and 16 weeks.

Timeline

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

  1. First posted8 Sep 2025
  2. Study start1 Aug 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion3 Dec 2027 (estimated)

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07158723
Sponsor's protocol ID
2503592283
Status last verified
Sep 2025
First submitted
19 Aug 2025
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Higher protein dietary pattern and Calorie restriction in people with Polycystic Ovary Syndrome (PCOS), run by University of Arkansas, Fayetteville at 2 sites 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean body mass (time frame: 0 and 16 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Sep 2025.

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