The effect of replacing regular salt with SmartSalt® mineral salt on blood pressure in middle-aged subjects with high blood pressure or with mild hypertension: a randomised controlled two-arm human study

Smart Salt Inc. (USA)0 个研究点目标入组 50 人开始时间: 2010年1月27日最近更新: 2015年1月13日

试验速览

暂无简介。

•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)

•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

发起方

Smart Salt Inc. (USA)