I10.0
Conditions
Interventions
Group 1: Verum group
Randomly selected group of participants will be taking MgMivela, 2 bottles of 500 ml each, (500 ml in the morning and 500 ml in the late afternoon/early evening), total of 1L per
Sponsors
Jamnica d.d.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: blood pressure. Method: Blood pressure will be assessed on V1-V4 (screening (V1), baseline (V2, 2 weeks after V1), control (V3, 4 weeks after baseline) and final visit (V4, 8 weeks after baseline)). Seated blood pressure measurements are taken in a quiet environment after subjects have been seated for about 15 minutes upon arrival (to be documented in the CRF). Subjects have to be seated with their feet located on the floor, their legs not crossed and their back placed against the back of a chair in a comfortable manner. The time of day of the measurements has to be documented. Three blood pressure measurements will be performed with 1-5 minutes intervals inbetween. The first measurement should be disregarded and the mean of the later two should be calculated. A trained investigator using a device with an universal cuff (for arm circumferences of 22 to 42 cm) should perform the measurements. The measurement should be done in triplicate according to a standardized method. At screening visit, BP measurements should be performed on both arms; in case of difference, the arm with the higher pressure (dominant arm) should be used. The decision, which arm is used for BP measurements will be documented in the source data and CRF. Measurements should be done: - Using the same arm - Using the same method and equipment - With the arm supported at heart level and slightly flexed at the elbow - At similar time of day per subject (within 07:30 -12:00) (time must be documented in the CRF) - For each individual subject preferably by the same investigator (investigator must be documented in the CRF) - Preferably avoiding gender discordance between investigator and subject (gender must be documented in the CRF) - Whenever possible, the investigator and the subject should not talk during the measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: Lipid metabolism, general well-being and body weight. Methods: Assessment of lipid metabolism Laboratory analysis for serum triglyceride levels, total cholesterol levels, LDL- and HDLC levels will be performed at V2 - V4. Following sampling after fasting overnight for at least 10 hours, venous blood samples will be transported to a central laboratory for analysis. Blood sampling should always be performed after blood pressure measurement. General well-being is assessed by the self-reported and validated SF-12 (Short Form 12 Health Survey Questionnaire). It is a validated questionnaire containing 12 items clustered into eight dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological well being). The acute version of the SF-12 covering a 1-week recall period will be used. SF-12 will be implemented at Visit 2, Visit 3 and Visit 4 and a copy will be part of the CRF. Physical activity is assessed by the international physical activity questionnaire (IPAQ-SF) at Visit 2, 3 and Visit 4. The IPAQ-SF is a validated tool for the assessment of physical activity during the week prior to assessment. Body weight (kg) will be assessed on V1-V4 in subjects wearing underwear and no shoes using calibrated weighing scales. | — |
Countries
Germany
Contacts
Public ContactUte Pohl
a&r
Outcome results
None listed