Effect of a dietary supplement on high-normal blood pressure

Not Applicable

• Conditions: High-normal (130–139/85–89 mmHg) baseline blood pressure; Circulatory System; Blood pressure

• Registration Number: ISRCTN13991711
• Lead Sponsor: BioCC OÜ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-06
• Last Update Posted: 21 February 2022
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Change in systolic blood pressure (SBP) at 8 weeks from baseline:<br> 1. Measurements will be done with a mercury sphygmomanometer (Riester No 1002 DIPLOMAT presameter, Rudolf Riester GmbH, Germany)<br> 2. Subjects will be instructed to avoid any strenuous exercise and stimulants (alcohol, caffeine) for at least 24 hours before any BP measurement and refrain from cold exposure, food and fluid intake and smoking for at least 1 hour before any BP measurement<br> 3. All measurements will be done at the same time of day per subject and within 07:00 hours and 13:00 hours for all subjects by a properly trained practicing nurse at the Tartu University Clinics<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change in SBP at 4 weeks from baseline<br> 2. Change in diastolic blood pressure (DBP) at 8 weeks from baseline<br> 3. Change in DBP at 4 weeks from baseline<br> 4. Change in SBP at 8 weeks from level at 4 weeks<br> 5. Change in DBP at 8 weeks from level at 4 weeks<br><br> Measurements will be done with a mercury sphygmomanometer (Riester No 1002 DIPLOMAT presameter, Rudolf Riester GmbH, Germany); subjects will be instructed to avoid any strenuous exercise and stimulants (alcohol, caffeine) for at least 24 hours before any BP measurement and refrain from cold exposure, food and fluid intake and smoking for at least 1 hour before any BP measurement; and all measurements will be done at the same time of day per subject and within 07:00 hours and 13:00 hours for all subjects by a properly trained practicing nurse at the Tartu University Clinics<br>