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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. august 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

36

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Texas
      • College Station, Texas, Forente stater, 77843
        • Rekruttering
        • Texas A&M AgriLife
        • Ta kontakt med:
        • Underetterforsker:
          • Michele Garant, DO
        • Underetterforsker:
          • Seung-Yeon "Shawn" Ha, PhD
        • Underetterforsker:
          • Lilian Ademu, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: Beef+
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in HbA1c
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in 2-hour Fasting Glucose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Compliance- Lean beef intake by self-report
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Texas A&M University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

30. april 2028

Studiet fullført (Antatt)

30. april 2028

Datoer for studieregistrering

Først innsendt

7. august 2026

Først innsendt som oppfylte QC-kriteriene

19. august 2026

Først lagt ut (Faktiske)

21. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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