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

Not Applicable

Completed

• Conditions: Healthy Participants
• Interventions: Other: Alkaline drinking-water; Other: Neutral drinking-water

• Registration Number: NCT02917616
• Lead Sponsor: The Novo Nordisk Foundation Center for Basic Metabolic Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-04
• Status Verified: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Last Update Submitted: 2016-09-27
• Study First Posted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alkaline water	Alkaline drinking-water	Two liters (minimum) daily of alkaline drinking-water (pH=9) for 14 days
Neutral Water	Neutral drinking-water	Two liters (minimum) daily of neutral drinking-water (pH=7) for 14 days

Primary Outcome Measures

Name	Time	Method
Shannon's alpha diversity index	Intervention day 14	Diversity of the gut microbial community

Secondary Outcome Measures

Name	Time	Method
Bray-Curtis	Intervention day 14	Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of Bray-Curtis distances
Estimated richness	Intervention day 14	Number of operational taxonomic units estimated using the Chao1 method
Serum insulin; global	Intervention day 14	Global test of intervention effect on serum insulin concentration during an oral glucose tolerance test
Simpsons' reciprocal diversity index	Intervention day 14	Diversity of the gut microbial community
Unweighted UniFrac	Intervention day 14	Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of unweighted UniFrac distances
Operational taxonomic unit	Intervention day 14	Relative abundance of individual operational taxonomic units
Plasma glucose; individual timepoints	Intervention day 14	Intervention effect on plasma glucose concentration at individual timepoints druing an oral glucose tolerance test
Observed richness	Intervention day 14	Observed number of operational taxonomic units
Weighted UniFrac	Intervention day 14	Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of weighted UniFrac distances
Bacterial genera	Intervention day 14	Relative abundance of operational taxonomic units aggregated at genus level
High sensitivity C-reactive protein	Intervention day 14
Plasma glucose; global	Intervention day 14	Global test of intervention effect on plasma glucose concentration during an oral glucose tolerance test
Serum insulin; individual timepoints	Intervention day 14	Intervention effect on serum insulin concentration at individual timepoints druing an oral glucose tolerance test