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

Healthy Participants Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917616
• Other study ID #: H-15011825
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: September 27, 2016
• Start date: November 2015

Study information

• Verified date: September 2016
• Source: The Novo Nordisk Foundation Center for Basic Metabolic Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Other:
• Alkaline drinking-water

• Neutral drinking-water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Novo Nordisk Foundation Center for Basic Metabolic Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shannon's alpha diversity index	Diversity of the gut microbial community	Intervention day 14	No
Secondary	Simpsons' reciprocal diversity index	Diversity of the gut microbial community	Intervention day 14	No
Secondary	Observed richness	Observed number of operational taxonomic units	Intervention day 14	No
Secondary	Estimated richness	Number of operational taxonomic units estimated using the Chao1 method	Intervention day 14	No
Secondary	Unweighted UniFrac	Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of unweighted UniFrac distances	Intervention day 14	No
Secondary	Weighted UniFrac	Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of weighted UniFrac distances	Intervention day 14	No
Secondary	Bray-Curtis	Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of Bray-Curtis distances	Intervention day 14	No
Secondary	Operational taxonomic unit	Relative abundance of individual operational taxonomic units	Intervention day 14	No
Secondary	Bacterial genera	Relative abundance of operational taxonomic units aggregated at genus level	Intervention day 14	No
Secondary	Plasma glucose; global	Global test of intervention effect on plasma glucose concentration during an oral glucose tolerance test	Intervention day 14	No
Secondary	Serum insulin; global	Global test of intervention effect on serum insulin concentration during an oral glucose tolerance test	Intervention day 14	No
Secondary	Serum insulin; individual timepoints	Intervention effect on serum insulin concentration at individual timepoints druing an oral glucose tolerance test	Intervention day 14	No
Secondary	Plasma glucose; individual timepoints	Intervention effect on plasma glucose concentration at individual timepoints druing an oral glucose tolerance test	Intervention day 14	No
Secondary	High sensitivity C-reactive protein		Intervention day 14	No