NCT02917616 - The Effect of Drinking-Water pH on the Human Gut Microbiota | Crick | Crick

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

N/ACompletedNCT02917616

The Novo Nordisk Foundation Center for Basic Metabolic Research30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

30

Conditions

Healthy Participants

Interventions

Alkaline drinking-waterOTHER

Neutral drinking-waterOTHER

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Shannon's alpha diversity index

Diversity of the gut microbial community

Time frame: Intervention day 14

Secondary Outcomes

Simpsons' reciprocal diversity index

Diversity of the gut microbial community

Time frame: Intervention day 14

Observed richness

Observed number of operational taxonomic units

Time frame: Intervention day 14

Estimated richness

Number of operational taxonomic units estimated using the Chao1 method

Time frame: Intervention day 14

Unweighted UniFrac

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

Time frame: Intervention day 14

Weighted UniFrac

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

Time frame: Intervention day 14

Bray-Curtis

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

Time frame: Intervention day 14

Operational taxonomic unit

Relative abundance of individual operational taxonomic units

Time frame: Intervention day 14

Data from ClinicalTrials.gov

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