Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

Primary objective-

• To assess the ability of KEFPEP® to reduce blood pressure.

Secondary objective-

• To access the effect of KEFPEP® on vascular inflammation or damage.
• To access the effect of KEFPEP® on cardiovascular diseases prevention.
• To assess the safety of KEFPEP® .

Inclusion criteria

• Male or female patient ages 20 years or older.
• Belong to either one of the following categories based on the Seventh Report of the Joint National Committee (JNC 7) as measured by office BP at Screening visit:

• Prehypertension (SBP 120 - 139 mmHg or DBP 80 - 89 mmHg)
• Stage I hypertension (SBP 140 - 159 mmHg or DBP 90 - 99 mmHg)
• Body weight≤90 kg, and BMI≥18.5 kg/m2 or < 30 kg/m2.
• NOT on any antihypertensive treatment at the time of entry into the study.
• Willing to comply with the study procedures and follow-ups.
• Understand the nature of the study, and have signed informed consent forms.

Exclusion criteria

• Patients with any of the following conditions within 6 months prior to study participation:

• Secondary hypertension
• Uncontrolled diabetes mellitus
• Renal disease based on the investigator's judgment
• Severe hepatic disease with Child-Pugh class C
• Severe anaemia
• Any malignant disease or serious disease
• Patients with clinically significant abnormalities in the following laboratory parameters within 2 weeks prior to Screening visit or during the screening period:

• HbA1c > 9%
• AST or ALT ≥ 3 x upper limit of normal (ULN)
• Estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2
• Serum creatinine ≥ 3 x ULN
• Hemoglobin < 10 g/dL
• History of milk allergy and/or lactose intolerance.
• History of alcohol abuse.
• Constant use of oral medication or supplements affecting blood pressure.
• Female patients who are pregnant, planning to become pregnant, or lactating.
• Male or female patients of child-bearing potential do not agree to use an effective method of contraception during the study period.
• Currently participating in any other interventional clinical study within 30 days
• Patients who are considered not suitable for the study according to the investigator's judgment for the patient's best interest.