Lean Beef as Part of a Healthy Meal Plan for Adolescent Girls with PCOS/PMOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot randomized controlled trial enrolling 36 adolescent females with PCOS/PMOS to test a dietary intervention called Beef+ that emphasizes lean, unprocessed beef as part of a healthy meals plan. The study aims to improve glycemic control, overall diet quality, and health-related quality of life while reducing saturated fat, sodium, and added sugars. The intervention will compare Beef+ to usual dietary habits and will assess feasibility, acceptability, and potential effects on satiety and glycemic measures using continuous glucose monitoring and dietary assessments. Eligible participants are ages 11 to 17 with BMI at or above the 85th percentile and a suspected or confirmed PCOS diagnosis, able to read and speak English. The trial is led by Texas A&M University with sites at Texas A&M AgriLife in College Station, TX.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female Adolescent
* 11-17 years old
* Suspected or confirmed diagnosis of PCOS
* ≥1-year post-menarche
* BMI ≥85th percentile for age/height
* Able to read and speak English

Exclusion Criteria:

* Medications affecting glucoregulation, metabolic health, and/or appetite (e.g., metformin, GLP-1)
* Unable or unwilling to eat beef
* Pregnant or planning pregnancy during study
* HbA1c ≥6.5%
* Unwilling or unable to complete study procedures
* Conditions affecting ability to complete study procedures or the intervention such as gastrointestinal diseases or syndromes, bleeding disorders, ongoing or unresolved eating disorder)
* Conditions affecting reproductive function other than PCOS
* Conditions that may interfere with continuous glucose monitor (CGM) application or use, including dermatological conditions such as eczema or allergies/reactions to medical adhesives

Conditional Exclusion Criteria:

\- Current use of hormonal contraceptives if in the suspected PCOS group (allowable if current for at least the previous 3 months with physician-confirmed PCOS)

Where it's running

• Texas A&M AgriLife
  College Station, Texas, United States Recruiting

Study contacts

• Principal investigator: Heidi K Vanden Brink, PhD, MSc, RDMS — Texas A&M University
• Study coordinator: Heidi K Vanden Brink, PhD, MSc, RDMS
• Email: heidi.vandenbrink@ag.tamu.edu
• Phone: 979-321-7073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.