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)
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Heidi K Vanden Brink, PhD, MSc, RDMS
- Numer telefonu: 979-321-7073
- E-mail: heidi.vandenbrink@ag.tamu.edu
Lokalizacje studiów
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Texas
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College Station, Texas, Stany Zjednoczone, 77843
- Rekrutacyjny
- Texas A&M AgriLife
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Kontakt:
- Heidi Vanden Brink
- Numer telefonu: 979--321-7073
- E-mail: heidi.vandenbrink@ag.tamu.edu
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Pod-śledczy:
- Michele Garant, DO
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Pod-śledczy:
- Seung-Yeon "Shawn" Ha, PhD
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Pod-śledczy:
- Lilian Ademu, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Brak interwencji: 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.
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Eksperymentalny: Beef+
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in HbA1c
Ramy czasowe: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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HbA1c measured as point of care using A1CNow+ point-of-care analyzer, HbA1c will also serve as a safety endpoint.
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Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in 2-hour Fasting Glucose
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Derived from a 75g oral glucose tolerance test (OGTT) as a measure of glycemic variability
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Dropout rate
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Drop-out and the reason for drop-out will be recorded, and in both the intervention and usual lifestyle groups will be reported.
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Change in Matsuda Index
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Change in Insulinogenic Index
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Derived from the 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Change in Disposition Index
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Derived from a 75g oral glucose tolerance test (OGTT), measure of insulin sensitivity
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Change in 2nd Phase Insulin Release
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Derived from a 75g oral glucose tolerance test (OGTT), as a measure of insulin sensitivity
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Change in Time in Range
Ramy czasowe: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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Derived from blinded Continuous Glucose Monitor (CGM) wear, a measure of glycemic variability
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Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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Change in Continuous Overall Net Glycemic Action (CONGA)
Ramy czasowe: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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Derived from blinded Continuous Glucose Monitor (CGM) wear, as a metric of glycemic variability
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Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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Change in Glycemic Risk Assessment in Diabetes Education (GRADE)
Ramy czasowe: Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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Derived from blinded Continuous Glucose Monitor (CGM) wear, measure of glycemic variability
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Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle
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Change in Diet Quality - Dietary Recalls
Ramy czasowe: Baseline and Week 14
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This will be assessed from 24-hour diet recalls and evaluated via Healthy Eating Index (HEI).
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Baseline and Week 14
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Change in Diet Quality - Skin Carotenoids
Ramy czasowe: Baseline and Week 14
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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.
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Baseline and Week 14
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Change in Perceived Hunger
Ramy czasowe: Baseline and Week 14
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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.
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Baseline and Week 14
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Change in incident Pre and Type 2 Diabetes
Ramy czasowe: Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle
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Type 2 Diabetes is defined as HbA1c >6.5%.
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Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle
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Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Compliance- Lean beef intake by self-report
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Intake of lean beef, assessed via 24-hour diet recalls
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Compliance - Daily Survey
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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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.
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Compliance - Blood Biomarkers
Ramy czasowe: Baseline and Week 12 of Intervention or Usual Lifestyle
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Serum hemoglobin will also be assessed as a metric of compliance.
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Baseline and Week 12 of Intervention or Usual Lifestyle
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Participants' Quality of Life
Ramy czasowe: Baseline and and Week 14
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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.
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Baseline and and Week 14
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Household Quality of Life
Ramy czasowe: Baseline and Week 14
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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.
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Baseline and Week 14
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Exploratory Analysis - Lean Beef
Ramy czasowe: Baseline and Week 14
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An exploratory analysis will reveal whether lean beef was directly associated with any change in glycemic outcome over time
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Baseline and Week 14
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Economic Evaluation of the Intervention (Ancillary Study, Optional)
Ramy czasowe: Baseline and Week 14
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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
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Baseline and Week 14
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Heidi K Vanden Brink, PhD, MSc, RDMS, Texas A&M University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Choroby układu hormonalnego
- Procesy patologiczne
- Zaburzenia odżywiania
- Nowotwory
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Przekarmienie
- Masy ciała
- Choroby narządów płciowych, kobiety
- Choroby jajników
- Choroby przydatków
- Zaburzenia gonad
- Choroby skórne
- Wady wrodzone
- Choroby włosów
- Torbiele jajników
- Cysty
- Zaburzenia rozwoju płciowego
- Zaburzenia układu moczowo-płciowego
- Wirylizm
- 46, XX Zaburzenia rozwoju płci
- Zespół nadnerczy
- Wrodzone, dziedziczne i noworodkowe choroby i nieprawidłowości
- Stany patologiczne, oznaki i objawy
- Choroby żywieniowe i metaboliczne
- Choroby skóry i tkanki łącznej
- Objawy i symptomy
- Nadwaga
- Zespół policystycznych jajników
- Hirsutyzm
- Zaburzenia miesiączkowania
- Hiperandrogenizm
- Żywność
- Dieta, żywność i odżywianie
- Zjawiska fizjologiczne
- Jedzenie i napoje
- Mięso
- Czerwone Mięso
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- IRB#STUDY2026-0483
- #2681 (Inny identyfikator: National Cattlemen's Beef Association, a contractor to the Beef Checkoff)
- Lab Research Funds (Inny identyfikator: Texas A&M AgriLife)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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