Pilot study with MgMivela mineral water to explore potential effects on cardiovascular parameters
- Conditions
- I10.0
- Registration Number
- DRKS00009383
- Lead Sponsor
- Jamnica d.d.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Males and females
• age 18-65 years
• high normal or hypertension grade 1 (130-159 / 85-99) screening blood pressure levels (mean of the second and third measurement during the assessment in triplicate at V1)
• BMI 18.5 - 29.9 kg/m2
• commitment to adhere to former diet and physical activity
• commitment to personally use the investigational product
• commitment to abstain from consumption of any mineral water other than IP during the study
• commitment to abstain from magnesium supplementation during the study
• (permitted) concomitant medication stable for at least 2 weeks prior to study inclusion
• stable body weight for at least 3 months prior to study inclusion (<3 kg weight change)
• hs-CRP < 10 mg/dl
• fasting glucose < 126 mg/dl
• HbA1c < 6.5%
• negative pregnancy testing (beta HCG-test in urine) at inclusion in females of childbearing potential (premenopausal women without surgical sterilization)
• women of child-bearing potential: willingness to use reliable method of contraception
• women of child-bearing potential: pregnant or breast-feeding
• excessive alcohol consumption, according to the investigator’s opinion
• use of any recreational drugs
• currently under psychiatric care or neuroleptics treatment
• secondary hypertension
• uncontrolled diabetes (type I or II) or diagnosed within the last 6 months prior to study inclusion
• history of clinical cardiovascular disease (e.g. myocardial infarction, angina pectoris, stroke, heart failure) or life-threatening arrhythmia within the last 6 months prior to study inclusion
• known congenital heart defects
• history of malignancy within 5 years prior to study inclusion
• untreated or non-stabilised thyroid disorder
• any metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator’s opinion could interfere with the results of the study or the safety of the subject
• other clinically relevant excursions of safety parameters
• any supplementation (magnesium, potassium, vitamin D, secondary plant metabolites or other botanicals, fish oil etc.) and/or any preparations that could affect the blood pressure (e.g. antihypertensive drugs etc.) including natural products within 14
days prior to study inclusion and during the study
• known sensitivity to one of the ingredients of the investigational product
• participation in any other studies during the last 30 days prior to study inclusion
• subjects who are not able to communicate with site study staff, or who are cognitively impaired, or unable to give informed consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method