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Recruiting
NCT07780188
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
Conditions: PCOS (Polycystic Ovary Syndrome), Obese Adolescents, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight Adolescents, Irregular Menstrual Cycle, Irregular Menstrual Cycles, Hirsutism, Hyperandrogenism
Sex: Female
Ages: 11 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Texas A&M University
Location: Texas A&M AgriLife College Station Texas
Summary
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 (\
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07780188). StuddyBuddy aggregates publicly available trial information.