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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+)

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

研究概览

地位

招聘中

条件

干预/治疗

其他：Beef+

详细说明

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).

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Heidi K Vanden Brink, PhD, MSc, RDMS
电话号码：979-321-7073
邮箱：heidi.vandenbrink@ag.tamu.edu

学习地点

美国
- Texas
  - College Station、Texas、美国、77843
    - 招聘中
    - Texas A&M AgriLife
    - 接触：
      
      Heidi Vanden Brink
      
      电话号码：979--321-7073
      
      邮箱：heidi.vandenbrink@ag.tamu.edu
    - 副研究员：
      
      Michele Garant, DO
    - 副研究员：
      
      Seung-Yeon "Shawn" Ha, PhD
    - 副研究员：
      
      Lilian Ademu, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子

接受健康志愿者

不

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：支持治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
无干预：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.
实验性的：Beef+	其他：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.

参与者组/臂

干预/治疗

无干预：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.

实验性的：Beef+

其他：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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in HbA1c 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Change in 2-hour Fasting Glucose 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

其他结果措施

结果测量	措施说明	大体时间
Compliance- Lean beef intake by self-report 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Texas A&M University

调查人员

首席研究员：Heidi K Vanden Brink, PhD, MSc, RDMS、Texas A&M University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年4月30日

研究完成 (估计的)

2028年4月30日

研究注册日期

首次提交

2026年8月7日

首先提交符合 QC 标准的

2026年8月19日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

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)

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

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