Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

Not Applicable

Completed

• Conditions: Prehypertension
• Interventions: Other: Placebo; Dietary Supplement: KEFPEP®

• Registration Number: NCT06393621
• Lead Sponsor: National Chung Hsing University

Brief Summary

To assess the ability of KEFPEP® to reduce blood pressure

Detailed 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® .

Study Timeline

• Study Start: 2018-07-26
• Primary Completion: 2023-04-18
• Study Completion: 2023-08-28
• Study First Submitted: 2024-03-20
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reduction of 5 mmHg SBP	At week 12	I. Reduction of 5 mmHg from Baseline in office SBP. II. Reduction of 5 mmHg from Baseline in 24-hour ambulatory SBP.
Reduction of 10 mmHg SBP	At week 12	I. Reduction of 10 mmHg from Baseline in office SBP. II. Reduction of 10 mmHg from Baseline in 24-hour ambulatory SBP.

Secondary Outcome Measures

Name	Time	Method
Biomarkers of blood vessel damage	Baseline (Day 1/Visit 3) and Week 12 (Visit 6)	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.
Follow-up and safety analyses -Adverse events (AEs)	The 2-week follow-up period once completing the 12-week dietary	Adverse events were according to MedDRA version 26.0, and all events were classified according to Preferred Terms (PT) and System Organ Class (SOC).
Office SBP and diastolic blood pressure (DBP)	Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6)	Compare the change from Baseline in office SBP and DBP
24-hour ambulatory	Baseline (Day 1/Visit 3) and Week 12 (Visit 6)	Compare the change from Baseline in 24-hour ambulatory SBP and 24-hour ambulatory DBP
Biomarkers of blood vessel inflammation	Baseline (Day 1/Visit 3) and Week 12 (Visit 6)	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.
Follow-up and safety analyses -Vital signs	The 2-week follow-up period once completing the 12-week dietary	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.)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan