Health Trials

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

ConditionsPCOS (Polycystic Ovary Syndrome)Obese AdolescentsOverweight (Without Type 2 Diabetes) With Weight-related ComorbiditiesOverweight AdolescentsIrregular Menstrual CycleIrregular Menstrual CyclesHirsutismHyperandrogenism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age11-17
SponsorTexas A&M University

About this trial

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

Eligibility criteria

Qualifiers

Female Adolescent

11-17 years old

Suspected or confirmed diagnosis of PCOS

≥1-year post-menarche

Disqualifiers

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%

Trial design

Treatments tested in this trial

  • Beef+

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Texas A&M University

Lead sponsor

Source ClinicalTrials.gov