Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in hemoglobin A1c
研究概览
简要总结
Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.
详细描述
Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •per diabetes, ability to follow diet and study procedures
排除标准
- •on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy
研究组 & 干预措施
Regular diet
Meals and snacks will contain carrageenan in the amount consumed in the typical daily diet and will be selected by the study dietician and distributed to study subjects randomized to the regular diet study arm.
干预措施: Regular Diet (Other)
No-carrageenan diet
No-carrageenan diet will be composed of meals and snacks selected by the study dietician and distributed to study participants who are randomized to the no-carrageenan diet study arm.
干预措施: No-carrageenan diet (Other)
结局指标
主要结局
Change in hemoglobin A1c
时间窗: baseline, 12 weeks
Measurements performed after 12 weeks of dietary intervention
次要结局
- Impact on glucose tolerance test(12 weeks)
- Impact on insulin level(12 weeks)
- Change in Tumor Necrosis Factor-alpha in serum(baseline, 12 weeks)
- Change in insulin signaling pathway(baseline, 12 weeks)
- Change in serum Interleukin-8(baseline, 12 weeks)
- Change in leukocyte subsets(baseline, 12 weeks)
研究者
Joanne Kramer Tobacman
Associate Professor
University of Illinois at Chicago