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NCT Number: NCT07780188

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

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. Change in HbA1c

    Time frame: Baseline, 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.

Secondary outcomes

  1. Change in 2-hour Fasting Glucose

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Derived from a 75g oral glucose tolerance test (OGTT) as a measure of glycemic variability

  2. Dropout rate

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Drop-out and the reason for drop-out will be recorded, and in both the intervention and usual lifestyle groups will be reported.

  3. Change in Matsuda Index

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity

  4. Change in Insulinogenic Index

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Derived from the 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity

  5. Change in Disposition Index

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity

  6. Change in 2nd Phase Insulin Release

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Derived from a 75g oral glucose tolerance test (OGTT), as a measure of insulin sensitivity

  7. Change in Time in Range

    Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle

    Derived from blinded Continuous Glucose Monitor (CGM) wear, a measure of glycemic variability

  8. Change in Continuous Overall Net Glycemic Action (CONGA)

    Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle

    Derived from blinded Continuous Glucose Monitor (CGM) wear, as a metric of glycemic variability

  9. Change in Glycemic Risk Assessment in Diabetes Education (GRADE)

    Time frame: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle

    Derived from blinded Continuous Glucose Monitor (CGM) wear, measure of glycemic variability

  10. Change in Diet Quality - Dietary Recalls

    Time frame: Baseline and Week 14

    This will be assessed from 24-hour diet recalls and evaluated via Healthy Eating Index (HEI).

  11. Change in Diet Quality - Skin Carotenoids

    Time frame: Baseline and Week 14

    Skin carotenoids will be measured through the Veggie Meter ®, which uses reflection spectroscopy to estimate skin carotenoid levels. Three scans will be taken on your non-dominant ring finger. After each scan, a dial gauge and a score will appear on the screen. A final score, calculated as the average of the three scans, will range from 0 to 800. Higher scores indicate greater fruit and vegetable intake.

  12. Change in Perceived Hunger

    Time frame: Baseline and Week 14

    This will be measured through an Appetite/Satiety Questionnaire adapted from commonly used appetite assessment methods and previously applied in dietary intervention research. Participants will report their general appetite and satiety experiences using six items assessing hunger frequency, strength of hunger before meals, fullness after eating, desire to eat when food is available, thoughts about food, and satisfaction after eating. Responses are recorded using a 100-mm visual analogue scale implemented as a 0-100 slider (0 = lowest intensity or frequency; 100 = highest intensity or frequency). Participants will be instructed to move the slider to reflect how strongly each statement describes their typical experience. Data collected will be used to evaluate changes in perceived hunger and fullness throughout the intervention.

  13. Change in incident Pre and Type 2 Diabetes

    Time frame: Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle

    Type 2 Diabetes is defined as HbA1c >6.5%.

Other outcomes

  1. Compliance- Lean beef intake by self-report

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Intake of lean beef, assessed via 24-hour diet recalls

  2. Compliance - Daily Survey

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Intake of lean beef, assessed through daily logs of beef intake by providing portion sized objects that align with serving sizes and ask participants to take photos of their meals with the portion estimator, to ensure that both the meal planning is followed and portion sizes are met.

  3. Compliance - Blood Biomarkers

    Time frame: Baseline and Week 12 of Intervention or Usual Lifestyle

    Serum hemoglobin will also be assessed as a metric of compliance.

  4. Participants' Quality of Life

    Time frame: Baseline and and Week 14

    This will be measured through the Pediatric Quality of Life (PedsQL) questionnaire. It includes 23 questions and is scored by reverse-scoring items and linearly transforming them to a 0-100 scale. Higher scores mean better health-related quality of life.

  5. Household Quality of Life

    Time frame: Baseline and Week 14

    This will be measured through the Adapted version of the Family Impact Module of the Pediatric Quality of Life (PedsQL). This questionnaire includes 36 questions and includes a 5-point Likert scale (0 to 4), reverse-scored and linearly transformed to a 0-100 scale. Higher scores show better parent health-related quality of life and family functioning with less negative impact.

  6. Exploratory Analysis - Lean Beef

    Time frame: Baseline and Week 14

    An exploratory analysis will reveal whether lean beef was directly associated with any change in glycemic outcome over time

  7. Economic Evaluation of the Intervention (Ancillary Study, Optional)

    Time frame: Baseline and Week 14

    An exploratory economic evaluation will estimate household food-related costs associated with participation in the intervention as an ancillary study. Parents or legal guardians will be invited to record and provide receipts for costs related to groceries or food purchased for at-home meal preparation, as well as for meals purchased outside the home, including at restaurants and fast-food venues

Study contacts

Contact information is provided by the study sponsor or research team.

Heidi K Vanden Brink, PhD, MSc, RDMS

CONTACT

[email protected]

979-321-7073

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

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)

Acronym: Beef+

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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