Condition category
Circulatory System
Date applied
11/11/2009
Date assigned
27/01/2010
Last edited
17/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mika Kastarinen

ORCID ID

Contact details

Neulaniementie 2 L 6
Kuopio
70210
Finland
mika.kastarinen@fimea.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VESU 5070

Study information

Scientific title

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

Acronym

Study hypothesis

The purpose of the study was to investigate the effect of replacing regular salt (NaCl) with SmartSalt® mineral salt on blood pressure in subjects with high blood pressure or with mild hypertension.

Ethics approval

The Ethics Committee of the Hospital District of Northern Savo approved on the 26th January 2009 (ref: DNRO 4/2009). An amendment of the protocol was approved on the 22nd September 2009.

Study design

Randomised double-blind (main study; follow-up was unblinded) controlled two-arm human study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

High blood pressure/mild hypertension

Intervention

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 consisted of three periods: a screening period (duration: 4 weeks +/- 7 days), an intervention period (duration: 8 weeks +/- 7 days) and an optional follow-up period (duration: 28 weeks +/- 14 days). The screening period included two study visits (-4 weeks and -2 weeks) and the intervention period included four visits (0 weeks, +3 weeks, +6 weeks and +8 weeks) and the optional follow-up period included two visits (+12 weeks and +28 weeks). After the screening period, 25 subjects were randomised to use Smart Salt® as a table salt and Smart Salt® salted foods (main dishes, bread, sausages and cheese, representing over 50% of the sodium sources in the diet) and 25 subjects were randomised to consume an equivalent regular salt (NaCl) diet respectively for a 8-week period.

Intervention type

Drug

Phase

Not Applicable

Drug names

SmartSalt® mineral salt

Primary outcome measures

Change in systolic blood pressure during intervention period measured with automatic sphygmomanometer after 10 minutes resting in sitting position.

Secondary outcome measures

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

Overall trial start date

09/02/2009

Overall trial end date

04/11/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

09/02/2009

Recruitment end date

04/11/2009

Locations

Countries of recruitment

Finland

Trial participating centre

Neulaniementie 2 L 6
Kuopio
70210
Finland

Sponsor information

Organisation

Smart Salt Inc. (USA)

Sponsor details

c/o Tapio Mäki
1261 Prospect Street
Suite 9
La Jolla
California
92037
United States of America
tapio.maki@smartsalt.com

Sponsor type

Industry

Website

http://www.smartsalt.com

Funders

Funder type

Industry

Funder name

Smart Salt Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21888642

Publication citations

  1. Results

    Sarkkinen ES, Kastarinen MJ, Niskanen TH, Karjalainen PH, Venäläinen TM, Udani JK, Niskanen LK, Feasibility and antihypertensive effect of replacing regular salt with mineral salt -rich in magnesium and potassium- in subjects with mildly elevated blood pressure., Nutr J, 2011, 10, 88, doi: 10.1186/1475-2891-10-88.

Additional files

Editorial Notes