High blood pressure/mild hypertension Circulatory System Essential (primary) hypertension
Conditions
Interventions
Test product: Smart Salt® mineral salt (sodium chloride [NaCl] 50%, potassium chloride 25%, magnesium ammoniumhexahydrate 25 %)
Placebo product: regular salt (sodium chloride, NaCl)
The study consis
Sponsors
Smart Salt Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 25 to 75 years (home-living subject) 2. High blood pressure or mild hypertension (systolic blood pressure [SBP] 130 - 159 mmHg or diastolic blood pressure [DBP] 85 - 99 mmHg) (mean of two measurements during the run-in period (visits -4 week and -2 week) 3. Body mass index 23 - 40 kg/m^2 4. Stable body weight (self-reported weight gain or loss less than 3 kg in the past three months) 5. Voluntarily signed informed consent (including willingness to fast 10 - 12 hours before blood samples and abstain from alcohol 2 days prior to blood sampling and abstain from cigarettes, caffeine and physical exercise at least 30 minutes before measurements)
Exclusion criteria
Exclusion criteria: 1. Antihypertensive drug treatment 2. Regular non-steroidal anti-inflammatory drug (NSAID) treatment and the use of ciclosporin or tacrolimus 3. Cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischaemic attack within six months prior to screening) including stroke and congestive heart failure 4. Anaemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function, except subjects on thyroid replacement therapy upon decision of investigator 5. Secondary hypertension 6. Diabetes (type 1 and type 2 diabetes) 7. History of cancer or malignant disease within the past five years 8. Low-salt diet: six or less points in the salt intake test (Finnish Heart Association, Helsinki) 9. Previous remarkable use of mineral salts products in daily diet (greater than 30% substitution) 10. Dietary restriction (coeliac disease, serious lactose intolerance, low-carbohydrate diet, sodium restriction, allergy to ingredients of test foods) 11. Alcohol abuse: subjects consuming more than 14 portions of alcohol per week 12. Drug abuse 13. Pregnant and lactating mothers 14. Women planning for pregnancy during the study 15. Participation in clinical trials 30 days prior to this study 16. Participation to other clinical trials during this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure during intervention period measured with automatic sphygmomanometer after 10 minutes resting in sitting position. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in diastolic blood pressure and mean of systolic and diastolic blood pressure and heart rate measured with an automatic sphygmomanometer after 10 minutes resting in sitting position. The measurement was repeated three times at intervals of at least two minutes and the mean of two last measurements was used as a result. The blood pressure measurements were made at visits -4 weeks, -2 weeks, 0 weeks, +3 weeks, +6 weeks, +8 weeks and at optional follow-up visits +12 weeks and +28 weeks. 2. 24-hour urinary sodium, potassium, magnesium and creatinine excretion measured just before the intervention (-1 day) and at visit +8 weeks 3. Urine pH measured at the study visits 0 weeks, +3 weeks and +8 weeks by stick test 4. Concentrations of plasma sodium, potassium, magnesium and creatitine measured at visits -4 weeks, 0 weeks and +8 weeks 5. The dietary intake of sodium calculated from 24-hour urinary sodium excretion and study subject's diaries 6. Body weight measured with calibrated digital scales at visits -4 weeks, 0 weeks, +3 weeks, +6 weeks and +8 weeks and optional follow-up visits +12 weeks and +28 weeks 7. Optionally concentrations of plasma renin, plasma aldosterone taken at visits 0 weeks and +8 weeks and serum C-peptide taken at visits 0 weeks, +3 weeks and +6 weeks and +8 weeks | — |
Countries
Finland
Outcome results
None listed