Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Insulin sensitivity (glucose infusion rate)
研究概览
简要总结
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.
详细描述
Plant-based diets that are abundant in myoinsitol and D-chiro inositol (MI and DCI) increase insulin sensitivity by promotion of insulin signaling lowering serum insulin and improving insulin resistance. The Western diet contributes to chronic metabolic inflammation often leading to the development of metabolic diseases. There is known metabolic improvement among men compared to women when following a plant-based diet or intensive lifestyle modifications. Through this study we look to identify the pathways in which plant-based diet impact skeletal muscle inositol metabolites among sexes (men vs. women) and improve insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index greater than or equal to 27
- •High waist circumference (women greater than or equal to 35"; men greater than or equal to 40")
- •Prediabetes (based on fasting glucose 100-125 mg/dL, HbA1c 5.7-6.4, or 2-hr post-oral glucose tolerance test glucose screen between 140-199mg/dL)
- •Physical activity below national guidelines
- •Aged 30-55 (premenopausal for women)
- •Following a Western diet
排除标准
- •Diabetes diagnosis
- •Take medications that may affect insulin sensitivity
- •More than 5% weight change within 6 months of screening
- •History of bariatric surgery
- •Report any dietary supplement, medication, or medical condition known to significantly affect weight or metabolism
- •Take hormone replacement therapy
- •Consume 3 or more servings of combined fruit and vegetables daily and/or 3 or more servings of whole grains daily
- •Any food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0 or allergy to lidocaine
结局指标
主要结局
Insulin sensitivity (glucose infusion rate)
时间窗: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.
This gold standard test for IS will be performed at baseline and post-intervention with support of the COBRE Phenotyping core. After ≥8 hour fast, participants will be admitted to our Center for Clinical and Translational Science (CCTS) and two IVs inserted; one for infusion, the other for blood draws (see Phenotyping core). The primary outcome is the glucose infusion rate (GIR), a direct measure of whole body IS, which will enable us to detect even small changes in IS in response to the intervention. COBRE mentor Dr. Kern is proficient in use of these methods The primary clinical outcome is the change in GIR from post run-in to post intervention.
Skeletal muscle d-chiroinositol content
时间窗: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.
Muscle samples will be homogenized, then inositol compounds will be extracted using solvents. In the prepared samples, D-chiroinositol content will be assessed by a commercial service using LC-MS/MS.
次要结局
- Phosphorylation status of insulin signaling molecules in skeletal muscle(The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.)
- Absolute change in visceral fat (g)(The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.)
- Fasting blood glucose(The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.)
研究者
Jean L. Fry
Assistant Professor- PI
University of Kentucky