Effects of the Resistant Starch and Sodium Butyrate Supplementation on the Respiratory and Cardiovascular Autonomic Control in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Arterial baroreflex sensitivity
研究概览
简要总结
Recent data feature short-chain fatty acids (SCFAs), products of gut microbial fermentation, as modulators of the blood pressure of the host. Such modulation may evoke (or arise from) changes in the autonomic reflexive mechanisms, but the link remains unexplored. Therefore, the study aims to explore potential relationship between the dietary intervention-induced changes in the SCFA plasma/fecal content and alterations in the sensitivity of the cardio-respiratory autonomic reflexes.
In this cross-over, placebo-controlled study, a group of healthy volunteers will undergo three distinct stages of a four-week dietary intervention, separated by at least two weeks of washout periods. During each stage, participants will receive one of the following interventions:
- raw potato starch (a source of resistant type 2 starch, which is a substrate for the endogenous production of SCFAs)
- sodium butyrate (a direct, exogenous source of this SCFA)
- an amylase-accessible waxy maze starch (a placebo). Plasma and fecal SCFA concentrations will be measured, along with the comprehensive evaluation of the cardio-respiratory parameters and the sensitivity of the autonomic reflexive mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-40 years
排除标准
- •chronic disease of the nervous, cardiovascular or respiratory system
- •disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
- •blood pressure-lowering treatment within the past year
- •tobacco smoking within the past year
- •antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment
研究组 & 干预措施
accessible maze starch
干预措施: Accessible starch supplementation (Dietary Supplement)
potato starch
干预措施: Potato starch supplementation (Dietary Supplement)
sodium butyrate
干预措施: Sodium butyrate supplementation (Dietary Supplement)
结局指标
主要结局
Arterial baroreflex sensitivity
时间窗: From the beginning to the end of a supplementation period at 4 weeks.
Arterial baroreflex sensitivity, measured with a neck chamber technique.
Peripheral chemoreflex sensitivity
时间窗: From the beginning to the end of a supplementation period at 4 weeks.
Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.
次要结局
- Plasma short-chain fatty acids(From the beginning to the end of a supplementation period at 4 weeks.)
研究者
Rafał Seredyński
Principal Investigator
Wroclaw Medical University