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临床试验/NCT02917616
NCT02917616已完成不适用

The Effect of Drinking-Water pH on the Human Gut Microbiota

The Novo Nordisk Foundation Center for Basic Metabolic Research0 个研究点目标入组 30 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Shannon's alpha diversity index

研究概览

简要总结

This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on the gut microbiota of healthy male volunteers.

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
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Non-smoker
  • •Age 18 - 35 years
  • •Weight stabile for at least 2 months
  • •BMI between 20.0 - 27.0 kg/m^2

排除标准

  • •Habitual consumption of caloric or artificially sweetened beverages in excess of 1L/week
  • •Habitual average consumption of alcohol in excess of 7 drinks/week
  • •Antibiotic treatment within two months of inclusion
  • •Chronic or acute illness
  • •Previous abdominal surgery

研究组 & 干预措施

Alkaline water

Experimental

Two liters (minimum) daily of alkaline drinking-water (pH=9) for 14 days

干预措施: Alkaline drinking-water (Other)

Neutral Water

Active Comparator

Two liters (minimum) daily of neutral drinking-water (pH=7) for 14 days

干预措施: Neutral drinking-water (Other)

结局指标

主要结局

Shannon's alpha diversity index

时间窗: Intervention day 14

Diversity of the gut microbial community

次要结局

  • Bray-Curtis(Intervention day 14)
  • Estimated richness(Intervention day 14)
  • Serum insulin; global(Intervention day 14)
  • Simpsons' reciprocal diversity index(Intervention day 14)
  • Unweighted UniFrac(Intervention day 14)
  • Operational taxonomic unit(Intervention day 14)
  • Plasma glucose; individual timepoints(Intervention day 14)
  • Observed richness(Intervention day 14)
  • Weighted UniFrac(Intervention day 14)
  • Bacterial genera(Intervention day 14)
  • High sensitivity C-reactive protein(Intervention day 14)
  • Plasma glucose; global(Intervention day 14)
  • Serum insulin; individual timepoints(Intervention day 14)

研究者

发起方
The Novo Nordisk Foundation Center for Basic Metabolic Research
申办方类型
Other
责任方
Sponsor

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