ISRCTN51761666
Recruiting
Not Applicable
Effect of a dietary supplement containing L. plantarum TENSIA® DSM21380 on subjects with high-normal blood pressure up to grade-1 hypertension: a randomised blinded placebo-controlled parallel designed two-armed study
BioCC LLC0 sites200 target enrollmentJune 11, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prehypertension
- Sponsor
- BioCC LLC
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent
- •2\. Age over 30 years
- •3\. Willingness to maintain a stable diet and physical activity level
- •4\. Normal or not clinically relevant deviations in safety laboratory values
- •5\. High normal or grade 1 systolic/diastolic blood pressure (\=159/99 mm Hg) with up to medium added risks in coronary\-heart diseases
- •6\. No use of any concomitant treatment (including blood pressure lowering drugs e.g. ACE\-inhibitors, blockers of beta adrenergic receptors, calcium channel blockers and diuretics) and lipid lowering drugs (e.g. statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid)
Exclusion Criteria
- •1\. Pregnancy and breastfeeding
- •2\. (Food) allergy
- •3\. Intolerance to the investigational product / its ingredients
- •4\. Diabetes
- •5\. Eating disorder
- •6\. Active weight loss \> 5 kg in prior 3 months
- •7\. Extensive exercise (daily trainings of professional athletes)
- •8\. Drug or alcohol abuse
- •9\. Participation in other studies within the last 30 days / during the study
- •10\. Any history of gastrointestinal diseases
Outcomes
Primary Outcomes
Not specified
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