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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Arkansas, Fayetteville

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Metabolic response to protein source

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Plant protein challengeActive comparator 1 intervention
Group B: Animal Protein ChallengeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Energy expenditure

Energy expenditure will be measured using indirect calorimetry.

Time frame
Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).

Secondary outcomes

1

Appetite

Participants will be asked to rate their perceived hunger, fullness, and desire to eat with the use of a traditional 100 mm visual analog scales (VAS) with opposing anchors (e.g., "extremely hungry" or "not hungry at all"). The questions include "how hungry do you feel at this moment," "how full do you feel at this moment," "how strong is your desire to eat at this moment," and "how much food do you think you could eat at this moment." Participants will also be asked to evaluate the appearance ("how much do you like or dislike the appearance of the breakfast foods") and palatability ("how much do you like or dislike the smell and taste of the breakfast foods") of the breakfast with the use of a traditional 100 mm visual analog scale with opposing anchors "dislike extremely" or "like extremely." Appetite assessments were measured at 0, 15, 30, 60, 120, and 240 min after the meal.

Time frame
Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
2

Plasma amino acid response

Plasma amino acids will be measured using UPLC

Time frame
Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
3

Plasma biomarkers related to appetite

Appetite biomarkers including PYY (Peptide YY), CCK (cholecystokinin), BDNF (brain-derived neurotrophic factor), GLP-1 (glucagon-like petide-1), and ghrelin will be measured using commercially available kits. This measurements will be interpreted together to make a conclusion about a appetite regulation in response to protein source.

Time frame
Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).

Other outcomes

Sponsors and contacts

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