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

NCT07780188 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-21

No results posted yet for this study

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 (\<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life

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

Interventions

OTHER

Beef+

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.

Sponsors & Collaborators

Principal Investigators

  • Heidi K Vanden Brink, PhD, MSc, RDMS · Texas A&M University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07780188 on ClinicalTrials.gov