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临床试验/NCT04229680
NCT04229680已完成不适用

The Salty Gut: Effects of High Dietary Salt Intake on the Gut Microbiota

University of Delaware2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Gut microbiota diversity

研究概览

简要总结

Gut microbiota has a role in cardiovascular disease and recent findings in rodents show dietary salt can negatively alter gut microbiota composition. High salt intake is a risk factor for cardiovascular disease. Americans consume dietary salt in excess of Dietary Guidelines and American Heart Association recommendations. The objective of this project is to investigate the influence of high dietary salt consumption on the gut microbiota composition in men and women.

详细描述

Gut microbiota composition and function has an important role in host physiology. In general, gut microbial diversity is positively correlated with health status. Recent evidence confirms the role of gut dysbiosis in cardiovascular disease. Americans consume 50% more salt than the amount recommended by the Dietary Guidelines and 130% more than recommended by the American Heart Association. Excess salt intake is considered a modifiable risk factor for cardiovascular disease. Changes in the gut microbiota composition followed by immune system activation is reported with high salt intake in animals. In particular, abundance of proinflammatory T helper 17 (Th17) cells increases with excess salt consumption. In contrast, T regulatory (Treg) cells oppose Th17 cell action and may aid in reducing inflammation associated with high salt intake, a hypothesis that has not yet been tested in humans. Only one preliminary study assessed changes in gut bacterial composition with high salt intake in humans, when only men were recruited. The study also found an increase in Th17 cell abundance. Thus, the objective of this study is to investigate the influence of high salt intake on the gut microbiota diversity and Th17 and Treg cell abundance in men and women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Single-blinded

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • normal blood pressure

排除标准

  • hypertension
  • cardiovascular disease
  • renal disease
  • current use of anti-inflammatory agents, glucocorticoids or other immune regulating medications, or certain anti-depressants
  • history of intestinal surgery
  • inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder
  • antibiotic use in the past 3 months
  • prebiotic, probiotic, or antioxidant supplementation in the past 3 months
  • ≥10 lbs weight gain or loss in the past 6 months
  • use of tobacco products
  • highly trained endurance athletes
  • current pregnancy or lactation

结局指标

主要结局

Gut microbiota diversity

时间窗: On day 10

The difference in gut microbiota diversity between the two arms.

T cell profile

时间窗: On day 10

The difference in T regulatory and T helper 17 cells between each arm.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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