Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in hs CRP
研究概览
简要总结
The study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.
详细描述
The primary aim of the proposed study is to determine whether the consumption of a prebiotic supplement (resistant starch) coupled with moderate intensity endurance training over 16 weeks leads to reductions in key inflammatory markers in stage 3-4 predialysis CKD patients and whether this reduction is associated with favorable changes in vascular function and indicators of stress and emotional reactivity.
The investigators hypothesize that supplementation with the prebiotic (resistant starch) will lead to normalization of the microbiome of our sample of patients with chronic kidney disease (CKD) and reduce key markers of inflammation. Reductions in these biomarkers will be associated with favorable changes in cardiovascular variables along with indices of stress and emotional reactivity. Moderate intensity aerobic training will have an additive anti-inflammatory effect along with the consumption of the resistant starch.
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 (Participant, Investigator)
盲法说明
This will be a double blind study. Neither the participant nor the investigator will know what substance (resistant starch or corn starch) the participants will be consuming.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage 3-4 of CKD (GFR 15-59 ml/min/1.73m2),
- •ages of 30-75 years old,
- •Must be capable of complying with and following the study protocol(diet and exercise)
- •Must be capable of independently giving informed consent
排除标准
- •kidney transplant
- •currently in a structured exercise program
- •on antibiotic therapy within the last month
- •On a probiotic or prebiotic supplement within the last month
- •a GI disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion
- •HIV positive
- •gastric by-pass surgery
- •clostridium difficile
- •marijuana user
- •rheumatoid arthritis
- •Hepatitis C
- •Post-traumatic stress disorder
- •deep vein thrombosis
- •pancreatitis
研究组 & 干预措施
Starch
Corn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks
干预措施: Starch (Behavioral)
Exercise
Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training.
干预措施: Exercise (Behavioral)
Resistant Starch
Resistant starch only: Patients randomized to this group will receive 30 g of resistant starch daily for 16 weeks. They will not be given an exercise training
干预措施: Resistant starch (Dietary Supplement)
Exercise & Resistant Starch
Exercise & resistant starch: Patients assigned to this group will do 16 weeks of personal training and they will be supplemented with 30 g of resistant starch daily for the 16 week period
干预措施: Resistant starch (Dietary Supplement)
Exercise & Resistant Starch
Exercise & resistant starch: Patients assigned to this group will do 16 weeks of personal training and they will be supplemented with 30 g of resistant starch daily for the 16 week period
干预措施: Exercise (Behavioral)
结局指标
主要结局
Change in hs CRP
时间窗: baseline and after 16 weeks
hsCRP
Change in TNF alpha
时间窗: Baseline and at week 16
TNFalpha
Change in IL6
时间窗: Baseline and at week 16
IL6
Change in IL10
时间窗: Baseline and at week 16
IL10
Change in MCP1
时间窗: Baseline and at week 16
MCP1
次要结局
- Change in vascular function(Baseline, week 8 and week 16)
- Change in blood pressure(Baseline & after 16 weeks)
- Change in microbiome composition(Baseline and after 16 weeks)
研究者
Samuel A. E. Headley, Ph.D FACSM
Professor Exercise Science & Sport Studies
Springfield College