The effect of replacing regular salt with SmartSalt® mineral salt on blood pressure in middle-aged subjects with high blood pressure or with mild hypertensio

Completed

• Conditions: High blood pressure/mild hypertension; Circulatory System; Essential (primary) hypertension

• Registration Number: ISRCTN01739816
• Lead Sponsor: Smart Salt Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified