Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07780188

Recruiting nowNot applicableInterventional

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age11 Years to 17 Years

SexFemale

Healthy volunteersNot accepted

ConditionPCOS (Polycystic Ovary Syndrome), Obese Adolescents, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities, Overweight Adolescents, Irregular Menstrual Cycle, Irregular Menstrual Cycles, Hirsutism, Hyperandrogenism

Full registry 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)

Treatments and study arms

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.

Primary outcomes

Change in HbA1cBaseline, Week 6 and Week 12 of Intervention or Usual Lifestyle

HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Texas A&M AgriLife🇺🇸 College Station, Texas, United States

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Heidi Vanden BrinkContact

Email · Call 979--321-7073

Michele Garant, DOSub Investigator

Seung-Yeon "Shawn" Ha, PhDSub Investigator