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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)

Effect of Increasing Lean Beef Intake as Part of a Healthy Meal Plan on Glycemic Control in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
11 Years to 17 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a healthy meal plan called “Beef+” that includes unprocessed, lean beef with less than 10% fat. It is for girls ages 11–17 with suspected or confirmed PCOS, a condition that affects hormones and the ovaries. Researchers will see if the plan is practical and helps blood sugar, diet quality, and quality of life.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Girls ages 11–17.
  • Have suspected or confirmed PCOS.
  • Had their first period at least 1 year ago.
  • Have a body mass index (BMI), a measure of body size, at or above the 85th percentile for age and height.
  • Can read and speak English.

Who can't join

  • Take medicines that affect blood sugar, how the body uses food for energy, or appetite, such as metformin or GLP-1 medicines.
  • Cannot or will not eat beef, or cannot or will not complete study tasks.
  • Are pregnant or plan to become pregnant during the study.
  • Have an HbA1c of 6.5% or higher. This blood test measures average blood sugar.
  • Have a condition that makes study tasks or the meal plan hard to complete, such as digestive diseases, bleeding disorders, or an ongoing or unresolved eating disorder.
  • Have a condition other than PCOS that affects the reproductive system.
  • Have a condition that makes it hard to wear or use a continuous blood sugar monitor, such as eczema or a reaction to medical adhesives.
  • Use hormonal birth control and have only suspected PCOS. With doctor-confirmed PCOS, use is allowed if it has continued for at least the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

TX