To assess the ability of KEFPEP® to reduce blood pressure
Primary objective- • To assess the ability of KEFPEP® to reduce blood pressure. Secondary objective- 1. To access the effect of KEFPEP® on vascular inflammation or damage. 2. To access the effect of KEFPEP® on cardiovascular diseases prevention. 3. To assess the safety of KEFPEP® .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
National Taiwan University Hospital
Taipei, Taiwan
Reduction of 5 mmHg SBP
I. Reduction of 5 mmHg from Baseline in office SBP. II. Reduction of 5 mmHg from Baseline in 24-hour ambulatory SBP.
Time frame: At week 12
Reduction of 10 mmHg SBP
I. Reduction of 10 mmHg from Baseline in office SBP. II. Reduction of 10 mmHg from Baseline in 24-hour ambulatory SBP.
Time frame: At week 12
Office SBP and diastolic blood pressure (DBP)
Compare the change from Baseline in office SBP and DBP
Time frame: Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6)
24-hour ambulatory
Compare the change from Baseline in 24-hour ambulatory SBP and 24-hour ambulatory DBP
Time frame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
Biomarkers of blood vessel inflammation
Biomarker: high sensitivity C-Reactive Protein (hsCRP); Unit of Measure: mg/L (milligrams per liter). By separating these biomarkers into distinct outcome measures, it ensures clarity in reporting and analysis, especially when different units of measure are involved.
Time frame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
Biomarkers of blood vessel damage
Biomarker: creatine kinase; Unit of Measure: U/L (unit per liter). By separating these biomarkers into distinct outcome measures, it ensures clarity in reporting and analysis, especially when different units of measure are involved.
Time frame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
Follow-up and safety analyses -Vital signs
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Measure the subject's body temperature (°C), respiratory rate per minute, and heartbeat/pulse per minute. (Measured the subject's sitting office blood pressure at revisit. At each measurement, the subject should rest in an air-conditioned space for approximately 30 minutes until the blood pressure stabilizes before using an electronic sphygmomanometer to measure the blood pressure while seated. The subject's body temperature (°C), respiratory rate per minute, and heartbeat/pulse per minute were displayed simultaneously in the electronic blood pressure monitor.)
Time frame: The 2-week follow-up period once completing the 12-week dietary
Follow-up and safety analyses -Adverse events (AEs)
Adverse events were according to MedDRA version 26.0, and all events were classified according to Preferred Terms (PT) and System Organ Class (SOC).
Time frame: The 2-week follow-up period once completing the 12-week dietary