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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) (Beef+)

19 de agosto de 2026 actualizado por: Heidi Vanden Brink, Texas A&M University

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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

36

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Texas
      • College Station, Texas, Estados Unidos, 77843
        • Reclutamiento
        • Texas A&M AgriLife
        • Contacto:
        • Sub-Investigador:
          • Michele Garant, DO
        • Sub-Investigador:
          • Seung-Yeon "Shawn" Ha, PhD
        • Sub-Investigador:
          • Lilian Ademu, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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+
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in HbA1c
Periodo de tiempo: 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.
Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in 2-hour Fasting Glucose
Periodo de tiempo: Baseline and Week 12 of Intervention or Usual Lifestyle
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
Periodo de tiempo: 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.
Baseline and Week 12 of Intervention or Usual Lifestyle
Change in Matsuda Index
Periodo de tiempo: Baseline and Week 12 of Intervention or Usual Lifestyle
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
Periodo de tiempo: Baseline and Week 12 of Intervention or Usual Lifestyle
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
Periodo de tiempo: Baseline and Week 12 of Intervention or Usual Lifestyle
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
Periodo de tiempo: Baseline and Week 12 of Intervention or Usual Lifestyle
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
Periodo de tiempo: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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)
Periodo de tiempo: 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
Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
Change in Glycemic Risk Assessment in Diabetes Education (GRADE)
Periodo de tiempo: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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
Periodo de tiempo: Baseline and Week 14
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
Periodo de tiempo: 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.
Baseline and Week 14
Change in Perceived Hunger
Periodo de tiempo: 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.
Baseline and Week 14
Change in incident Pre and Type 2 Diabetes
Periodo de tiempo: Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle
Type 2 Diabetes is defined as HbA1c >6.5%.
Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Compliance- Lean beef intake by self-report
Periodo de tiempo: Baseline and Week 12 of Intervention or Usual Lifestyle
Intake of lean beef, assessed via 24-hour diet recalls
Baseline and Week 12 of Intervention or Usual Lifestyle
Compliance - Daily Survey
Periodo de tiempo: 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.
Baseline and Week 12 of Intervention or Usual Lifestyle
Compliance - Blood Biomarkers
Periodo de tiempo: Baseline and Week 12 of Intervention or Usual Lifestyle
Serum hemoglobin will also be assessed as a metric of compliance.
Baseline and Week 12 of Intervention or Usual Lifestyle
Participants' Quality of Life
Periodo de tiempo: 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.
Baseline and and Week 14
Household Quality of Life
Periodo de tiempo: 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.
Baseline and Week 14
Exploratory Analysis - Lean Beef
Periodo de tiempo: Baseline and Week 14
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)
Periodo de tiempo: 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
Baseline and Week 14

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Texas A&M University

Investigadores

  • Investigador principal: Heidi K Vanden Brink, PhD, MSc, RDMS, Texas A&M University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de abril de 2028

Finalización del estudio (Estimado)

30 de abril de 2028

Fechas de registro del estudio

Enviado por primera vez

7 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de agosto de 2026

Publicado por primera vez (Actual)

21 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB#STUDY2026-0483
  • #2681 (Otro identificador: National Cattlemen's Beef Association, a contractor to the Beef Checkoff)
  • Lab Research Funds (Otro identificador: Texas A&M AgriLife)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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