Healthy ParticipantsNCT02917616
The Effect of Drinking-Water pH on the Human Gut Microbiota
A study testing Alkaline drinking-water and Neutral drinking-water in people with Healthy Participants, run by The Novo Nordisk Foundation Center for Basic Metabolic Research.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Alkaline drinking-water and Neutral drinking-water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Non-smoker
- Age 18 - 35 years
- Weight stabile for at least 2 months
- BMI between 20.0 - 27.0 kg/m^2
Who cannot join
- 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
About this study
This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on the gut microbiota of healthy male volunteers.
- Conditions
- Healthy Participants
- Being tested
- Alkaline drinking-water, Neutral drinking-water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkaline drinking-waterOther
Neutral drinking-waterOther
| Study group | Role | What they receive |
|---|---|---|
| Alkaline water | Experimental | Two liters (minimum) daily of alkaline drinking-water (pH=9) for 14 days Receives: Other: Alkaline drinking-water |
| Neutral Water | Active comparator | Two liters (minimum) daily of neutral drinking-water (pH=7) for 14 days Receives: Other: Neutral drinking-water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shannon's alpha diversity index
Diversity of the gut microbial community
Measured: Intervention day 14
Secondary outcomes (13)
Simpsons' reciprocal diversity index
Diversity of the gut microbial community
Measured: Intervention day 14
Observed richness
Observed number of operational taxonomic units
Measured: Intervention day 14
Estimated richness
Number of operational taxonomic units estimated using the Chao1 method
Measured: Intervention day 14
Unweighted UniFrac
Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of unweighted UniFrac distances
Measured: Intervention day 14
Weighted UniFrac
Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of weighted UniFrac distances
Measured: Intervention day 14
Bray-Curtis
Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of Bray-Curtis distances
Measured: Intervention day 14
Operational taxonomic unit
Relative abundance of individual operational taxonomic units
Measured: Intervention day 14
Bacterial genera
Relative abundance of operational taxonomic units aggregated at genus level
Measured: Intervention day 14
Plasma glucose; global
Global test of intervention effect on plasma glucose concentration during an oral glucose tolerance test
Measured: Intervention day 14
Serum insulin; global
Global test of intervention effect on serum insulin concentration during an oral glucose tolerance test
Measured: Intervention day 14
Serum insulin; individual timepoints
Intervention effect on serum insulin concentration at individual timepoints druing an oral glucose tolerance test
Measured: Intervention day 14
Plasma glucose; individual timepoints
Intervention effect on plasma glucose concentration at individual timepoints druing an oral glucose tolerance test
Measured: Intervention day 14
High sensitivity C-reactive protein
Measured: Intervention day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Novo Nordisk Foundation Center for Basic Metabolic Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oluf Pedersen, MD, DMSc, Principal investigator, The Novo Nordisk Foundation Center for Basic Metabolic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917616
- Sponsor's protocol ID
- H-15011825
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymised datasets generated during the current study are available from the corresponding author on reasonable request
Publications
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.
PubMed 30413727
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Drinking-Water pH on the Human Gut Microbiota
- ClinicalTrials.gov ID
- NCT02917616
- Acronym / sponsor ID
- H-15011825
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Novo Nordisk Foundation Center for Basic Metabolic ResearchUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on the gut microbiota of healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alkaline water | Experimental | Other: Alkaline drinking-waterTwo liters (minimum) daily of alkaline drinking-water (pH=9) for 14 days |
| Neutral Water | Active comparator | Other: Neutral drinking-waterTwo liters (minimum) daily of neutral drinking-water (pH=7) for 14 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Non-smoker
- Age 18 - 35 years
- Weight stabile for at least 2 months
- BMI between 20.0 - 27.0 kg/m^2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alkaline drinking-water | Other | Alkaline water |
| Neutral drinking-water | Other | Neutral Water |
Primary outcome
Shannon's alpha diversity index
Time frame: Intervention day 14
Diversity of the gut microbial community
13 secondary outcomes
Simpsons' reciprocal diversity index
Time frame: Intervention day 14
Observed richness
Time frame: Intervention day 14
Estimated richness
Time frame: Intervention day 14
Unweighted UniFrac
Time frame: Intervention day 14
Weighted UniFrac
Time frame: Intervention day 14
Bray-Curtis
Time frame: Intervention day 14
Operational taxonomic unit
Time frame: Intervention day 14
Bacterial genera
Time frame: Intervention day 14
Plasma glucose; global
Time frame: Intervention day 14
Serum insulin; global
Time frame: Intervention day 14
Serum insulin; individual timepoints
Time frame: Intervention day 14
Plasma glucose; individual timepoints
Time frame: Intervention day 14
High sensitivity C-reactive protein
Time frame: Intervention day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Derived from this study: PubMed 30413727Hansen 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.
- Individual participant dataSharing planned: Yes. Anonymised datasets generated during the current study are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oluf Pedersen, MD, DMSc principal investigator
The Novo Nordisk Foundation Center for Basic Metabolic Research
Questions about this trial
What is this clinical trial studying?
A study testing Alkaline drinking-water and Neutral drinking-water in people with Healthy Participants, run by The Novo Nordisk Foundation Center for Basic Metabolic Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shannon's alpha diversity index (time frame: Intervention day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.