ISOLeucine Addition Treatment Effects (ISOLATE) in a Controlled Diet Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in insulin sensitivity (M value)
研究概览
简要总结
The primary purpose of this study is to determine whether isoleucine repletion attenuates increases in insulin sensitivity typically observed when people with obesity follow a healthy, low-isoleucine diet.
详细描述
Isoleucine restriction promotes insulin sensitivity in preclinical models and is a promising strategy for preventing type 2 diabetes. This project aims to identify clinical and molecular changes in skeletal muscle and adipose tissues when adults with obesity switch from a typical American style diet to a plant-based diet low in isoleucine with or without isoleucine repletion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting at least three metabolic syndrome criteria
- •Follow an American style diet
排除标准
- •Type 1 or 2 Diabetes diagnosis
- •Medical condition or medication that affects insulin sensitivity, weight, or metabolism
- •More than 5% weight change in 3 previous months
- •Restrictive dietary pattern
- •History of bariatric surgery
- •Food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0
- •Allergy to lidocaine.
研究组 & 干预措施
Isoleucine group
Participants will be randomized to receive low-isoleucine diet and isoleucine supplement
干预措施: Low-isoleucine diet (Other)
Placebo group
Participants will be randomized to receive low-isoleucine diet and placebo supplement
干预措施: Low-isoleucine diet (Other)
Isoleucine group
Participants will be randomized to receive low-isoleucine diet and isoleucine supplement
干预措施: L-Isoleucine (Dietary Supplement)
结局指标
主要结局
Change in insulin sensitivity (M value)
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 low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
The primary clinical outcome is insulin sensitivity, quantified as the M value derived from the hyperinsulinemic-euglycemic clamp. Hyperinsulinemic-euglycemic clamps will be performed to measure insulin sensitivity (IS). Briefly, after a ≥8 hour fast, participants will be admitted to the PC clinical unit and two IVs will be inserted; one for infusion, the other for blood draws. The primary metric will be an absolute change in M value from baseline to post intervention.
次要结局
- Change in ratio of phosphorylation IRS-1 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 low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.)
- Absolute change in visceral fat(The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.)
- Change in ratio of phosphorylation Akt 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 low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.)
研究者
Jean L. Fry
Associate Professor-PI
University of Kentucky