Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2023-08-28

Brief Summary

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To assess the ability of KEFPEP® to reduce blood pressure

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Detailed Description

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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® .

Conditions

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Prehypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

KEFPEP®

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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KEFPEP®

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes