Clinical trial NCT06393621: Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Lead sponsor: National Chung Hsing University
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2024-05-01
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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® .

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of 5 mmHg SBP
timeFrame: At week 12
measure: Reduction of 10 mmHg SBP
timeFrame: At week 12
Secondary outcomes:
measure: Office SBP and diastolic blood pressure (DBP)
timeFrame: Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6)
measure: 24-hour ambulatory
timeFrame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
measure: Biomarkers of blood vessel inflammation
timeFrame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
measure: Biomarkers of blood vessel damage
timeFrame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
measure: Follow-up and safety analyses -Vital signs
timeFrame: The 2-week follow-up period once completing the 12-week dietary
measure: Follow-up and safety analyses -Adverse events (AEs)
timeFrame: The 2-week follow-up period once completing the 12-week dietary
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jen-Kuang Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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/