Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

NCT06393621 | Completed DMC

• 2 other identifiers: PHP1705H01201707074MIPC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the ability of KEFPEP® to reduce blood pressure

Conditions

Prehypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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)

• 24-hour ambulatory

  Baseline (Day 1/Visit 3) and Week 12 (Visit 6)

• Biomarkers of blood vessel inflammation

  Baseline (Day 1/Visit 3) and Week 12 (Visit 6)

• Biomarkers of blood vessel damage

  Baseline (Day 1/Visit 3) and Week 12 (Visit 6)

• Follow-up and safety analyses -Vital signs

  The 2-week follow-up period once completing the 12-week dietary

Study Arms (2)

KEFPEP®

EXPERIMENTAL

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.

Dietary Supplement: KEFPEP®

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

KEFPEP® DIETARY_SUPPLEMENT

Twice daily (one pack before breakfast and the other before dinner)

KEFPEP®

Placebo OTHER

Twice daily (one pack before breakfast and the other before dinner)

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient ages 20 years or older.
• 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)
• Body weight≤90 kg, and BMI≥18.5 kg/m2 or \< 30 kg/m2.
• NOT on any antihypertensive treatment at the time of entry into the study.
• Willing to comply with the study procedures and follow-ups.
• Understand the nature of the study, and have signed informed consent forms.

You may not qualify if:

• 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
• 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
• History of milk allergy and/or lactose intolerance.
• History of alcohol abuse.

Sponsors & Collaborators

• National Chung Hsing University: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related 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.

  PMID: 14656957 BACKGROUND

• 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.

  PMID: 16305721 BACKGROUND

• 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/

  PMID: 32208570 BACKGROUND

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jen-Kuang Lee, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: May 1, 2024
• Study Start: July 26, 2018
• Primary Completion: April 18, 2023
• Study Completion: August 28, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)