ClinicalTrials.gov record NCT07780188

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age11 years old to 17 years old
SexFemale
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized pilot study (Beef+) tests a 12-week dietary program emphasizing unprocessed, lean beef as part of healthy meals. It is for adolescent females with PCOS/PMOS who are overweight or obese. The study compares the Beef+ program with usual lifestyle and measures blood sugar control, continuous glucose patterns, diet quality, and feasibility.

What it is studying. The study tests whether replacing higher-fat or processed red meat with unprocessed, lean beef (<10% fat) consumed as part of a healthy meal plan affects glucoregulation (blood sugar control), overall diet quality and satiety, and whether the approach is feasible and acceptable for participants and their households. It also measures related outcomes such as continuous glucose patterns and health-related quality of life.

What the researchers hope to learn. The scientific goals are to evaluate whether incorporating lean beef into healthy meals improves glucoregulation, enhances diet quality and satiety, and is a feasible, acceptable strategy that could improve participant and household health-related quality of life.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Beef+

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Youth-onset Type 2 Diabetes (T2D) is a chronic disease characterized by accelerated beta cell decline and severe insulin resistance (IR). Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a well-established independent risk factor for youth-onset T2D. A first line of treatment for PCOS is lifestyle intervention; however, there is a paucity of evidence evaluating the effectiveness of nutritional strategies in adolescents with PCOS. The overarching goal of the pilot study, termed Beef+, is to replace intake of high fat, processed red meat products with lean beef ("Beef") prepared as part of healthy meals that target increased vegetable and complex carbohydrate intake per the Dietary Guidelines for Americans ("+") and reducing intake of saturated fat, sodium, and added sugar. We will test the hypothesis that incorporating lean beef as part of a healthy meal plan will improve glucoregulation (Aim 1), enhance overall diet quality and satiety (Aim 2), and be a feasible and acceptable dietary intervention strategy that improves participant and household health-related quality of life (Aim 3).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be randomly assigned to follow the Beef+ plan for 12 weeks or to continue their usual lifestyle; those in the delayed-control group may be offered one optional month of the Beef+ intervention after 12 weeks. Beef+ participants are asked to eat at least one 3‑oz serving per day of cooked, unprocessed lean beef (<10% fat) (about 21 oz/week); the study team will purchase the beef and a registered dietitian (RDN) will meet with the participant and a parent/guardian every two weeks to provide tailored dietary support. Study procedures include point-of-care HbA1c testing at baseline, week 6 and week 12; a 75 g oral glucose tolerance test (OGTT) at baseline and week 12 (a 2-hour test with blood draws); and blinded continuous glucose monitor (CGM) wear at baseline, week 6 and week 12. Other activities include 24-hour diet recalls, skin carotenoid scans (three fingertip scans), appetite/satiety questionnaires, and recording reasons for any drop-out; participants in the intervention receive a $100/month supplement to offset grocery costs.

How the study is structured. This is a randomized, parallel-group, single-masked interventional study. Participants are assigned to one of two arms: the Beef+ intervention or usual lifestyle (control), with an optional delayed one-month intervention offered to control participants after 12 weeks. Beef+ lasts 12 weeks and asks participants to eat at least one 3‑ounce serving per day of cooked unprocessed, lean beef (about 21 oz/week). The intervention is offered at the household level, includes bi-weekly check-ins with a registered dietitian nutritionist to provide tailored support and an implementation plan, the study team purchases the beef for the intervention, and participants receive a $100/month supplement to offset grocery costs. Measurements include point-of-care HbA1c at baseline, week 6, and week 12; a 75 g oral glucose tolerance test (OGTT) at baseline and week 12; blinded continuous glucose monitor (CGM) wear at baseline, week 6, and week 12; and diet-quality assessments (diet recalls and skin carotenoid scans) at baseline and week 14, plus questionnaires on appetite and related outcomes.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under 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. Does it apply to my diagnosis?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Sep 1, 2026 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Study completion
Apr 30, 2028 (estimated)
Target enrollment
36 participants (estimated)
Last updated on registry
Aug 21, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Texas A&M University
Principal investigator
Heidi Vanden Brink, Principal Investigator
Texas A&M University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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