Healthy
Conditions
Keywords
Calorimetry, Blood pressure, Immunophenotyping, Gut microbial composition
Brief summary
To perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota
Interventions
DIETARY_SUPPLEMENTSalt
10 capsules daily for 14 days
DIETARY_SUPPLEMENTPlacebo
10 capsules daily for 14 days
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women * 18 - 50 years * Body mass index 18.5 - 29.9 kg/m2
Exclusion criteria
* Clinically relevant heart, lung, liver, and kidney diseases * Current or chronic infection * Habitual use of probiotics or dietary supplements * Pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary induced thermogenis (%) | 14 days | Decrease of dietary induced thermogenis after salt vs. placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure (mmHg) | 14 days | Increase of systolic blood pressure after salt vs. placebo |
| Lymphocytic pro-inflammatory mediators | 14 days | Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo |
| Gut microbiome | 14 days | Change of gut microbiome composition after salt vs. placebo |
Countries
Germany
Outcome results
None listed