Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

Prehypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06393621
• Other study ID #: PHP1705H01
• Secondary ID: 201707074MIPC
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: August 28, 2023

Study information

• Verified date: April 2024
• Source: National Chung Hsing University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the ability of KEFPEP® to reduce blood pressure

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® .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 28, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

Dietary Supplement:
• KEFPEP®
Twice daily (one pack before breakfast and the other before dinner)

Other:
• Placebo
Twice daily (one pack before breakfast and the other before dinner)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Chung Hsing University	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

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. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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