Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) (Beef+)
2026年8月19日 更新者：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
調査の概要
状態
募集
介入・治療
詳細な説明
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).
研究の種類
介入
入学 (推定)
36
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Heidi K Vanden Brink, PhD, MSc, RDMS
- 電話番号：979-321-7073
- メール：heidi.vandenbrink@ag.tamu.edu
研究場所
-
-
Texas
-
College Station、Texas、アメリカ、77843
- 募集
- Texas A&M AgriLife
-
コンタクト：
- Heidi Vanden Brink
- 電話番号：979--321-7073
- メール：heidi.vandenbrink@ag.tamu.edu
-
副調査官：
- Michele Garant, DO
-
副調査官：
- Seung-Yeon "Shawn" Ha, PhD
-
副調査官：
- Lilian Ademu, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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.
|
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in HbA1c
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in 2-hour Fasting Glucose
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compliance- Lean beef intake by self-report
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Heidi K Vanden Brink, PhD, MSc, RDMS、Texas A&M University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年4月30日
研究の完了 (推定)
2028年4月30日
試験登録日
最初に提出
2026年8月7日
QC基準を満たした最初の提出物
2026年8月19日
最初の投稿 (実際)
2026年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21日
QC基準を満たした最後の更新が送信されました
2026年8月19日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
- 泌尿生殖器疾患
- 生殖器疾患
- 内分泌系疾患
- 病理学的プロセス
- 栄養障害
- 新生物
- 男性の泌尿生殖器疾患
- 女性の泌尿生殖器疾患
- 女性の泌尿生殖器疾患と妊娠合併症
- 過栄養
- 体重
- 生殖器疾患、女性
- 卵巣疾患
- 付属器疾患
- 性腺疾患
- 皮膚疾患
- 先天異常
- 毛髪疾患
- 卵巣嚢腫
- 嚢胞
- 性発達障害
- 泌尿生殖器の異常
- 男性主義
- 46、XX性発達障害
- 副腎性器症候群
- 先天性、遺伝性、および新生児の疾患と異常
- 病理学的状態、徴候および症状
- 栄養および代謝疾患
- 皮膚および結合組織疾患
- 徴候と症状
- 太りすぎ
- 多嚢胞性卵巣症候群
- 多毛症
- 月経障害
- 高アンドロゲン症
- 食べ物
- 食事、食物、栄養
- 生理学的現象
- 食べ物と飲み物
- 肉
- 赤身肉
その他の研究ID番号
- IRB#STUDY2026-0483
- #2681 (その他の識別子：National Cattlemen's Beef Association, a contractor to the Beef Checkoff)
- Lab Research Funds (その他の識別子：Texas A&M AgriLife)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。