Effect of a dietary supplement containing Lactobacillus plantarum TENSIA on the subpopulation with high-normal blood pressure: a randomised controlled double-blind phase 2 study

BioCC OÜ0 个研究点目标入组 23 人开始时间: 2015年2月6日最近更新: 2022年2月21日

适应症

试验速览

暂无简介。

•1. Desire to participate
•2. Age 18–65 years
•3. High-normal (130–139/85–89 mmHg) screening blood pressure
•4. Normal or not clinically significant deviations in safety laboratory values (clinical chemistry, blood count), white blood cell count <8800 million/L, high-sensitivity C-reactive protein <5 mg/L; fasting glucose <6.0mmol/L, serum creatinine in females <80 µmol/L, serum creatinine in males <106 µmol/L, glycated haemoglobin < 5.9%
•5. No use of any concomitant treatment including blood pressure lowering drugs (e.g., angiotensin-converting-enzyme 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) that could affect the evaluation of the efficacy and tolerability of the investigational study product within 1 month before the study start.
•6. Signed informed consent
•7. Willingness to maintain a stable diet and physical activity level

•1. History of any gastrointestinal disease
•2. Use of any antimicrobial drug within past month
•3. Use of any regular concomitant medication, including medical preparations, non-steroidal anti-inflammatory drugs and antioxidant vitamins
•4. Food allergy
•5. Diabetes and acute infection
•6. Pregnancy or breastfeeding
•7. SBP = 129 mmHg and/or DBP = 84 mmHg
•7.1. Hypertension (=140–159 / 90–99 mmHg)
•7.2. History or clinical signs of cardiovascular abnormalities (e.g., stroke), particularly cardiac arrhythmia and bradycardia (pulse rate <50 beats per minute)

发起方

BioCC OÜ