RECRUITING Not applicable ClinicalTrials.gov

Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)

Sponsor: Texas A&M University • ClinicalTrials.gov ID: NCT07780188

Registry updated: 2026-08-21

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Description

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

Interventions

Beef+ (Other)
Adolescents will be instructed to consume a minimum of 1 (3oz) serving per day of cooked unprocessed, lean (\<10% fat) beef (21 oz/week) for 12 weeks. To facilitate adoption, the intervention will be offered at the household level, but it is not a requirement. The intervention is a multi-modal behavior change intervention with three overarching components: modifying beef intake, consuming beef in healthy meals, and the research team purchasing the beef needed for the intervention. To facilitate adoption of lean beef as part of a healthy diet, a study RDN will meet with the participant and at least one representative parent/guardian at bi-weekly check-ins to provide tailored dietary support and develop an implementation plan. A financial supplement of $100/month will be provided offset grocery costs.

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)

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

Locations

Texas A&M AgriLife — College Station, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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