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Completed

NCT Number: NCT02917616

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

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

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Key information

Conditions

Healthy Participants

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Alkaline drinking-water

Other

Neutral drinking-water

Other

Primary outcomes

  1. Shannon's alpha diversity index

    Time frame: Intervention day 14

    Diversity of the gut microbial community

Secondary outcomes

  1. Simpsons' reciprocal diversity index

    Time frame: Intervention day 14

    Diversity of the gut microbial community

  2. Observed richness

    Time frame: Intervention day 14

    Observed number of operational taxonomic units

  3. Estimated richness

    Time frame: Intervention day 14

    Number of operational taxonomic units estimated using the Chao1 method

  4. Unweighted UniFrac

    Time frame: Intervention day 14

    Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of unweighted UniFrac distances

  5. Weighted UniFrac

    Time frame: Intervention day 14

    Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of weighted UniFrac distances

  6. Bray-Curtis

    Time frame: Intervention day 14

    Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of Bray-Curtis distances

  7. Operational taxonomic unit

    Time frame: Intervention day 14

    Relative abundance of individual operational taxonomic units

  8. Bacterial genera

    Time frame: Intervention day 14

    Relative abundance of operational taxonomic units aggregated at genus level

  9. Plasma glucose; global

    Time frame: Intervention day 14

    Global test of intervention effect on plasma glucose concentration during an oral glucose tolerance test

  10. Serum insulin; global

    Time frame: Intervention day 14

    Global test of intervention effect on serum insulin concentration during an oral glucose tolerance test

  11. Serum insulin; individual timepoints

    Time frame: Intervention day 14

    Intervention effect on serum insulin concentration at individual timepoints druing an oral glucose tolerance test

  12. Plasma glucose; individual timepoints

    Time frame: Intervention day 14

    Intervention effect on plasma glucose concentration at individual timepoints druing an oral glucose tolerance test

  13. High sensitivity C-reactive protein

    Time frame: Intervention day 14

Sponsors and collaborators

Lead sponsor

The Novo Nordisk Foundation Center for Basic Metabolic Research

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Sep 28, 2016
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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