NCT02917616

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

September 26, 2016

Last Update Submit

September 27, 2016

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • Shannon's alpha diversity index

    Diversity of the gut microbial community

    Intervention day 14

Secondary Outcomes (13)

  • Simpsons' reciprocal diversity index

    Intervention day 14

  • Observed richness

    Intervention day 14

  • Estimated richness

    Intervention day 14

  • Unweighted UniFrac

    Intervention day 14

  • Weighted UniFrac

    Intervention day 14

  • +8 more secondary outcomes

Study Arms (2)

Alkaline water

EXPERIMENTAL

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

Other: Alkaline drinking-water

Neutral Water

ACTIVE COMPARATOR

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

Other: Neutral drinking-water

Interventions

Alkaline drinking-waterOTHER
Alkaline water
Neutral drinking-waterOTHER
Neutral Water

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Habitual consumption of caloric or artificially sweetened beverages in excess of 1L/week
  • Habitual average consumption of alcohol in excess of 7 drinks/week
  • Chronic or acute illness
  • Previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30413727DERIVED

Study Officials

  • Oluf Pedersen, MD, DMSc

    The Novo Nordisk Foundation Center for Basic Metabolic Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

November 1, 2015

Primary Completion

April 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Anonymised datasets generated during the current study are available from the corresponding author on reasonable request