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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician is the outcome assessor who is blinded to randomziation.
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
Beef+
干预措施: Beef+ (Other)
结局指标
主要结局
Change in HbA1c
时间窗: 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.
次要结局
- Change in 2-hour Fasting Glucose(Baseline and Week 12 of Intervention or Usual Lifestyle)
- Dropout rate(Baseline and Week 12 of Intervention or Usual Lifestyle)
- Change in Matsuda Index(Baseline and Week 12 of Intervention or Usual Lifestyle)
- Change in Insulinogenic Index(Baseline and Week 12 of Intervention or Usual Lifestyle)
- Change in Disposition Index(Baseline and Week 12 of Intervention or Usual Lifestyle)
- Change in 2nd Phase Insulin Release(Baseline and Week 12 of Intervention or Usual Lifestyle)
- Change in Time in Range(Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle)
- Change in Continuous Overall Net Glycemic Action (CONGA)(Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle)
- Change in Glycemic Risk Assessment in Diabetes Education (GRADE)(Baseline, Week 6 and Week 12 of Intervention or Usual Lifestyle)
- Change in Diet Quality - Dietary Recalls(Baseline and Week 14)
- Change in Diet Quality - Skin Carotenoids(Baseline and Week 14)
- Change in Perceived Hunger(Baseline and Week 14)
- Change in incident Pre and Type 2 Diabetes(Baseline, Week 6, and Week 12 of Intervention or Usual Lifestyle)
研究者
Heidi Vanden Brink
Principal Investigator
Texas A&M University