Effects of Whey Protein-enriched Nutritional Supplement on Gut Microbiota and Inflammatory Status, in Patients Attending a Cardiac Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Pro-inflammatory cytokine interleukin 6 (IL-6)
研究概览
简要总结
In this randomized trial the primary outcome is to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 6 (IL-6).
Hypothesis: Secondary outcomes are to assess if high doses of whey protein supplement may lower pro-inflammatory interleukin 1β (IL-1 β), tumor necrosis factor and C Reactive Protein (CRP); may increase anti-inflammatory interleukin 10 (IL-10) plasma concentrations and may change Gut Microbiota (GM) composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission for cardiac rehabilitation
- •Signed informed consent
排除标准
- •Patient unable to eat orally
- •Eating disorders
- •Indication to Levodopa therapy
- •Gastrointestinal malignant diseases
- •Known kidney failure
- •Known liver failure
- •Previous antibiotic therapy
研究组 & 干预措施
whey protein-enriched nutritional supplement
Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water
干预措施: whey protein-enriched nutritional supplement (Dietary Supplement)
Control group
Standard hospital diet
干预措施: Control group (Other)
结局指标
主要结局
Pro-inflammatory cytokine interleukin 6 (IL-6)
时间窗: Baseline (T0) and day 15 (T1)
Change in IL-6 \[Time Frame: after 15 days (T1) from baseline (T0)\]
次要结局
- Anti- inflammatory cytokine interleukin 10 (IL-10)(Baseline (T0) and day 15 (T1))
- Gut Microbiota (GM)(Baseline (T0) and day 15 (T1))
- C-Reactive Protein (CRP)(Baseline (T0) and day 15 (T1))
- Pro-inflammatory cytokine interleukin 1beta (IL-1β)(Baseline (T0) and day 15 (T1))
- Tumor Necrosis Factor (TNF)(Baseline (T0) and day 15 (T1))