Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

Prospective, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

To assess the ability of KEFPEP® to reduce blood pressure

Study Overview

• Status: Completed
• Conditions: Prehypertension
• Intervention / Treatment: Dietary supplement: KEFPEP®; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KEFPEP®; Dosage form: Powder (directly take the powder with appropriate amount of warm water); Dose(s): Total 2.8 g kefir-fermented milk powder with increased peptide content 1.2 g.	Dietary supplement: KEFPEP®; Twice daily (one pack before breakfast and the other before dinner)
Placebo Comparator: Placebo; Dosage form: Powder (directly take the powder with appropriate amount of warm water).; Dose(s): Total 2.8 g starch power.	Other: Placebo; Twice daily (one pack before breakfast and the other before dinner)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office SBP and diastolic blood pressure (DBP)	Compare the change from Baseline in office SBP and DBP	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	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.	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.	Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
Follow-up and safety analyses -Vital signs	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.)	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).	The 2-week follow-up period once completing the 12-week dietary

Collaborators and Investigators

• Sponsor: National Chung Hsing University
• Collaborators: National Taiwan University Hospital
• Investigators: Principal Investigator: Jen-Kuang Lee, MD, National Taiwan University Hospital

Publications and helpful links

General Publications

• Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.
• Cholongitas E, Papatheodoridis GV, Vangeli M, Terreni N, Patch D, Burroughs AK. Systematic review: The model for end-stage liver disease--should it replace Child-Pugh's classification for assessing prognosis in cirrhosis? Aliment Pharmacol Ther. 2005 Dec;22(11-12):1079-89. doi: 10.1111/j.1365-2036.2005.02691.x.
• Chronic kidney disease in adults: assessment and management. London: National Institute for Health and Care Excellence (NICE); 2015 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK555204/

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: PHP1705H01; 201707074MIPC (Other Identifier: NTUH-REC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No