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

NCT ID: NCT02917616

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Brief Summary

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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

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Alkaline water

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

Group Type EXPERIMENTAL

Alkaline drinking-water

Intervention Type OTHER

Neutral Water

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

Group Type ACTIVE_COMPARATOR

Neutral drinking-water

Intervention Type OTHER

Interventions

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Alkaline drinking-water

Intervention Type OTHER

Neutral drinking-water

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Novo Nordisk Foundation Center for Basic Metabolic Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oluf Pedersen, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

The Novo Nordisk Foundation Center for Basic Metabolic Research

References

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Hansen TH, Thomassen MT, Madsen ML, Kern T, Bak EG, Kashani A, Allin KH, Hansen T, Pedersen O. The effect of drinking water pH on the human gut microbiota and glucose regulation: results of a randomized controlled cross-over intervention. Sci Rep. 2018 Nov 9;8(1):16626. doi: 10.1038/s41598-018-34761-5.

Reference Type DERIVED
PMID: 30413727 (View on PubMed)

Other Identifiers

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H-15011825

Identifier Type: -

Identifier Source: org_study_id

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