Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
Recruiting · NCT07780188 · Interventional (participants receive a specific treatment) · Lead sponsor: Texas A&M University
View the official record on ClinicalTrials.gov →Interventions studied
Beef+
What this trial is about
This pilot randomized controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to evaluate the effectiveness and feasibility of a tailored dietary intervention which will be termed "Beef+", that will emphasize the incorporation of unprocessed, lean beef (\<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life
Who can take part
Age range
11 Years to 17 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Texas A&M AgriLife - College Station, Texas, United States