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

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)

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

Study Overview

• Status: Recruiting
• Conditions: Hyperandrogenism; Overweight Adolescents; Hirsutism; Irregular Menstrual Cycle; Irregular Menstrual Cycles; PCOS (Polycystic Ovary Syndrome); Obese Adolescents; Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
• Intervention / Treatment: Other: Beef+

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi K Vanden Brink, PhD, MSc, RDMS; Phone Number: 979-321-7073; Email: heidi.vandenbrink@ag.tamu.edu

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843
      • Recruiting
      • Texas A&M AgriLife
      • Contact: Heidi Vanden Brink; Phone Number: 979--321-7073; Email: heidi.vandenbrink@ag.tamu.edu
      • Sub-Investigator: Michele Garant, DO
      • Sub-Investigator: Seung-Yeon "Shawn" Ha, PhD
      • Sub-Investigator: Lilian Ademu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control/Usual Lifestyle with optional Delayed Intervention; Participants randomized to usual lifestyle will continue with their usual lifestyle/ diet. Participants will undergo all scheduled study procedures. Upon completion of the 12-week of usual lifestyle, participants randomized to the delayed onset control group will be offered one month of the dietary intervention. The delayed intervention is optional.
Experimental: Beef+	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.	Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 2-hour Fasting Glucose	Derived from a 75g oral glucose tolerance test (OGTT) as a measure of glycemic variability	Baseline and Week 12 of Intervention or Usual Lifestyle
Dropout rate	Drop-out and the reason for drop-out will be recorded, and in both the intervention and usual lifestyle groups will be reported.	Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Matsuda Index	Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity	Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Insulinogenic Index	Derived from the 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity	Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Disposition Index	Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity	Baseline and Week 12 of Intervention or Usual Lifestyle
Change in 2nd Phase Insulin Release	Derived from a 75g oral glucose tolerance test (OGTT), as a measure of insulin sensitivity	Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Time in Range	Derived from blinded Continuous Glucose Monitor (CGM) wear, a measure of glycemic variability	Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Continuous Overall Net Glycemic Action (CONGA)	Derived from blinded Continuous Glucose Monitor (CGM) wear, as a metric of glycemic variability	Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Glycemic Risk Assessment in Diabetes Education (GRADE)	Derived from blinded Continuous Glucose Monitor (CGM) wear, measure of glycemic variability	Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Diet Quality - Dietary Recalls	This will be assessed from 24-hour diet recalls and evaluated via Healthy Eating Index (HEI).	Baseline and Week 14
Change in Diet Quality - Skin Carotenoids	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.	Baseline and Week 14
Change in Perceived Hunger	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.	Baseline and Week 14
Change in incident Pre and Type 2 Diabetes	Type 2 Diabetes is defined as HbA1c >6.5%.	Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance- Lean beef intake by self-report	Intake of lean beef, assessed via 24-hour diet recalls	Baseline and Week 12 of Intervention or Usual Lifestyle
Compliance - Daily Survey	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.	Baseline and Week 12 of Intervention or Usual Lifestyle
Compliance - Blood Biomarkers	Serum hemoglobin will also be assessed as a metric of compliance.	Baseline and Week 12 of Intervention or Usual Lifestyle
Participants' Quality of Life	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.	Baseline and and Week 14
Household Quality of Life	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.	Baseline and Week 14
Exploratory Analysis - Lean Beef	An exploratory analysis will reveal whether lean beef was directly associated with any change in glycemic outcome over time	Baseline and Week 14
Economic Evaluation of the Intervention (Ancillary Study, Optional)	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	Baseline and Week 14

Collaborators and Investigators

• Sponsor: Texas A&M University
• Investigators: Principal Investigator: Heidi K Vanden Brink, PhD, MSc, RDMS, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 19, 2026
• First Posted (Actual): August 21, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Polycystic Ovary Syndrome (PCOS); Randomized Control Trial; Dietary Intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Nutrition Disorders; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Skin Diseases; Congenital Abnormalities; Hair Diseases; Ovarian Cysts; Cysts; Disorders of Sex Development; Urogenital Abnormalities; Virilism; 46, XX Disorders of Sex Development; Adrenogenital Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Overweight; Polycystic Ovary Syndrome; Hirsutism; Menstruation Disturbances; Hyperandrogenism; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Meat; Red Meat
• Other Study ID Numbers: IRB#STUDY2026-0483; #2681 (Other Identifier: National Cattlemen's Beef Association, a contractor to the Beef Checkoff); Lab Research Funds (Other Identifier: Texas A&M AgriLife)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data is not anticipated to be shared on a publicly available database because this is not a federally funded study and given the nature of the data collected and vulnerable population.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No