Influence of a bicarbonate-sodium-mineral water on acid-base balance and cardiovascular health
- Conditions
- acid-base balance, lipid metabolism, blood pressure, pulse wave velocity
- Registration Number
- DRKS00025341
- Lead Sponsor
- eibniz Universität Hannover; Institut für Lebensmittelwissenschaft und Humanernährung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 94
Healthy, consent-capable men and women at the age of 30 - 65 years; BMI: 20,0 - 29,9 km/m2, omnivorous diet; written consent of the subjects after detailed oral and written information on study contents, requirements and risks; ability and willingness of the study participants to follow the instructions of the investigator (compliance with the study conditions, use of the test products according to the dosage recommendation, etc.), willingness to take part on the whole study procedure
Severe chronic diseases (e.g cancer, diabetes type I); manifest cardiovascular diseases, renal insufficiency, liver disease, chronic diseases of the gastrointestinal tract (colitis ulcerosa, Crohn's disease, pancreatic insufficiency); covid-19 disease (14 days before the start of the study or during the study); drug-treated hypertension; diagnosed blood coagulation disorders as well as use of anticoagulant drugs; surgery of the heart (stent, bypass, pacemaker); intake of any medication influencing the cardiovascular system, especially blood pressure (ACE inhibitors, aldosterone antagonists, angiotensin receptor blockers, beta blockers, diuretics); intake of any medication influencing the urinary pH value; intake of cholesterol-lowering drugs (e.g. statins, fibrates, bile acid exchange resins, phytosterols, ezetimibe) within the last three months before the planned start of the intervention; intake of magnesium-, calcium- and bicarbonate supplements, within the last 6-8 weeks before the planned start of the intervention; regular intake of laxatives; persons practicing alternative diets (e.g vegetarianism, veganism, paleo, food combining); alcohol, drug and/or medicine addiction; pregnancy or breastfeeding; non-consenting subjects and subjects unable to give consent; refusal or withdrawal of consent by the subject; simultaneous participation in another clinical study or participation in within the last 30 days; planned surgical procedures within the next 3 months; (official) quarantine because of Covid-19 contact ; non-compliance with study conditions, in particular insufficient consumption of test water (< 1000 ml/day)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The renal net acid excretion (NAE) is defined as the primary outcome. It is calculated as follows:<br>NAE = TA + NH4+ – HCO3- <br>The calculation is based on the analytical determination of the titrable acids (TA), ammonium (NH4+) and bicarbonate (HCO3-) in the 24-h urine; every examination day.
- Secondary Outcome Measures
Name Time Method 1. Every examination day: <br>PRAL values of food (calculated using a 3-day nutrition record) and mineral water;<br>Analytical parameters: fasting blood values (aldosterone, total cholesterol, HDL, LDL, glucose, HbA1c, insulin), blood gas analysis (BE, pCO2, HCO3-, pH), urine values (Mg, Ca, K, creatinine, uric acid, pH value, volume) Inflammation parameters (CRP, IL-6), liver enzymes (GOT, GPT, GGT);<br>Exercise behavior (questionnaire)<br><br>2. Baseline and final examination: <br>Anthropometry (measurements): blood pressure, pulse, height, weight, BMI, waist and hip circumference;<br>Arterial rigidity via PWV (measurement)<br>