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Recruiting NCT07142603

Appetite Response to Meals With Different Protein Sources in Women With PCOS

No phase Interventional Polycystic Ovary Syndrome (PCOS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metabolic response to protein source.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome (PCOS). Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Meal Response to Plant vs. Animal Protein in Women With PCOS

Overview

Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance, hyperandrogenism, and reproductive dysfunction. Dietary strategies that improve postprandial insulin and glucose responses are central to managing metabolic symptoms in PCOS. Meals higher in protein can attenuate postprandial glycemia and enhance satiety, but the effects may vary by protein source. Animal sources of protein typically have higher essential amino acid content and insulinogenic potential, whereas plant proteins offer fiber and phytochemicals that may influence glycemic dynamics differently. Few studies have directly compared the acute metabolic effects of plant versus animal protein in women with PCOS. Given the distinct pathophysiology of PCOS, extrapolating findings from healthy populations may be misleading. Understanding protein-specific effects on postprandial insulin, glucose, and appetite-regulating hormones in this group is essential for targeted nutrition guidance. Additionally, plant-based diets are increasingly promoted for cardiometabolic health, but their acute effects in insulin-resistant women remain underexplored. This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary recommendations aimed at improving metabolic outcomes in this high-risk population.

Interventions

  • Other Metabolic response to protein source
    Participants will be given a 350-400 kcal meal challenge containing 30% energy from animal protein. They will be given 10 minutes to consume the meal and meal response will be measured 240 minutes following the meal.

Primary outcome measures

  • Energy expenditure [Time frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).]
Secondary outcome measures (3)
  • Appetite [Time frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).]
  • Plasma amino acid response [Time frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).]
  • Plasma biomarkers related to appetite [Time frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).]

Eligibility criteria

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 or use of marijuana products
  • Food allergies or dietary restrictions incompatible with test meals
  • Diagnosed diabetes (type 1 or 2)
  • Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Center for Human Nutrition — Fayetteville

Identifiers

NCT: NCT07142603 · 2507614944

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗