Healthy Participants
Conditions
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.
Interventions
OTHERAlkaline drinking-water
OTHERNeutral drinking-water
Sponsors
The Novo Nordisk Foundation Center for Basic Metabolic Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shannon's alpha diversity index | Intervention day 14 | Diversity of the gut microbial community |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operational taxonomic unit | Intervention day 14 | Relative abundance of individual operational taxonomic units |
| Unweighted UniFrac | Intervention day 14 | Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of unweighted UniFrac distances |
| Weighted UniFrac | Intervention day 14 | Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of weighted UniFrac distances |
| Simpsons' reciprocal diversity index | Intervention day 14 | Diversity of the gut microbial community |
| Observed richness | Intervention day 14 | Observed number of operational taxonomic units |
| Estimated richness | Intervention day 14 | Number of operational taxonomic units estimated using the Chao1 method |
| Bray-Curtis | Intervention day 14 | Inter-individual diversity of the gut microbial community assessed using principal coordinate ordination of Bray-Curtis distances |
| Plasma glucose; global | Intervention day 14 | Global test of intervention effect on plasma glucose concentration during an oral glucose tolerance test |
| Serum insulin; global | Intervention day 14 | Global test of intervention effect on serum insulin concentration during an oral glucose tolerance test |
| Serum insulin; individual timepoints | Intervention day 14 | Intervention effect on serum insulin concentration at individual timepoints druing an oral glucose tolerance test |
| Plasma glucose; individual timepoints | Intervention day 14 | Intervention effect on plasma glucose concentration at individual timepoints druing an oral glucose tolerance test |
| High sensitivity C-reactive protein | Intervention day 14 | — |
| Bacterial genera | Intervention day 14 | Relative abundance of operational taxonomic units aggregated at genus level |
Outcome results
None listed