Animal and Plant Proteins and Glucose Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 24-hour plasma glucose concentration
研究概览
简要总结
The goal of this proposal is to determine the effect of a high protein diet in which the increase in protein intake is derived from different sources (animal vs plant and protein-rich whole foods vs protein isolates) on: i) liver and muscle insulin sensitivity; ii) the metabolic response to a meal, and iii) 24-h plasma concentration profiles of glucose, glucoregulatory hormones, and protein-derived metabolites purported to cause metabolic dysfunction.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: ≥21 and ≤70 years;
- •BMI: >24.5 and <32.5 kg/m2;
- •habitual protein intake <0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and
- •weight stable (i.e., ≤3% change) and untrained (≤150 min of structured exercise/week) for at least 2 months before entering the study.
排除标准
- •prediabetes or type 2 diabetes;
- •evidence of chronic kidney disease by medical history or laboratory tests (glomerular filtration rate <60 ml/min/1.73 m2 or an albumin to creatinine ratio in urine ≥30 mg/g);
- •vegetarians or vegans;
- •intolerance or allergies to ingredients in the metabolic meal or intervention diet;
- •take dietary supplements (e.g., pre- and probiotics, fiber, fish oil) or medications known to affect our study outcomes;
- •received antibiotic or antifungal treatment (which affect the microbiome and therefore microbial metabolite production) 2 months before entering the study;
- •consume tobacco products or excessive alcohol (women: >14 drinks/week; men: >21 drinks/week);
- •evidence of significant organ system dysfunction or diseases (e.g., cirrhosis), and
- •unwilling or unable to provide informed consent.
研究组 & 干预措施
Standard protein (control)
High animal protein whole food
干预措施: High animal protein whole food (Other)
High plant protein isolate
干预措施: High plant protein isolate (Other)
High plant protein whole food
干预措施: High plant protein whole food (Other)
High animal protein isolate
干预措施: High animal protein isolate (Other)
结局指标
主要结局
24-hour plasma glucose concentration
时间窗: up to 12 weeks after the intervention
Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure
时间窗: up to 12 weeks after the intervention
次要结局
- Postprandial plasma glucose concentration(up to 12 weeks after the intervention)
- mTOR signaling (phospho-S6 content) in circulating monocytes(up to 12 weeks after the intervention)
- Endothelial function, assessed as reactive hyperemia index(up to 12 weeks after the intervention)
- Postprandial plasma insulin concentration(up to 12 weeks after the intervention)
- Postprandial plasma amino acid concentration(up to 12 weeks after the intervention)
研究者
Bettina Mittendorfer
Senior Associate Dean for Research
University of Missouri-Columbia