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 个研究点目标入组 200 人开始时间: 2018年6月11日最近更新: 2018年7月2日

适应症

试验速览

暂无简介。

•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)

•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
•11. Acute infection within the last 2 weeks prior to baseline
•12. Use of any antimicrobial agents within the preceding 1 month
•13. Donor within the last 1,5 months prior to start of the study (i.e. baseline visit)
•14. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study
•15. Chronic inflammatory diseases

发起方

BioCC LLC