Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

National Chung Hsing University

Status: Completed

Conditions: Prehypertension

Treatments: Dietary Supplement: KEFPEP®; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06393621

PHP1705H01

201707074MIPC (Other Identifier)

Details and patient eligibility

About

To assess the ability of KEFPEP® to reduce blood pressure

Full description

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® .

Enrollment: 46 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female patient ages 20 years or older.

2. 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)

3. Body weight≤90 kg, and BMI≥18.5 kg/m2 or < 30 kg/m2.

4. NOT on any antihypertensive treatment at the time of entry into the study.

5. Willing to comply with the study procedures and follow-ups.

6. Understand the nature of the study, and have signed informed consent forms.

Exclusion criteria

1. 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

2. 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

3. History of milk allergy and/or lactose intolerance.

4. History of alcohol abuse.

5. Constant use of oral medication or supplements affecting blood pressure.

6. Female patients who are pregnant, planning to become pregnant, or lactating.

7. Male or female patients of child-bearing potential do not agree to use an effective method of contraception during the study period.

8. Currently participating in any other interventional clinical study within 30 days

9. Patients who are considered not suitable for the study according to the investigator's judgment for the patient's best interest.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

KEFPEP®

Experimental group

Description:

1. Dosage form: Powder (directly take the powder with appropriate amount of warm water) 2. Dose(s): Total 2.8 g kefir-fermented milk powder with increased peptide content 1.2 g.

Treatment:

Dietary Supplement: KEFPEP®

Placebo

Placebo Comparator group

Description:

1. Dosage form: Powder (directly take the powder with appropriate amount of warm water). 2. Dose(s): Total 2.8 g starch power.

Treatment:

Other: Placebo