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PrehypertensionNCT06393621

Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

A study testing KEFPEP® in people with Prehypertension, run by National Chung Hsing University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the ability of KEFPEP® to reduce blood pressure Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Prehypertension
What is being tested?
KEFPEP®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteTaiwan
Study dates
26 Jul 2018to 28 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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.
  • Constant use of oral medication or supplements affecting blood pressure.
  • Female patients who are pregnant, planning to become pregnant, or lactating.
  • Male or female patients of child-bearing potential do not agree to use an effective method of contraception during the study period.
  • Currently participating in any other interventional clinical study within 30 days
  • Patients who are considered not suitable for the study according to the investigator's judgment for the patient's best interest.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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

To assess the ability of KEFPEP® to reduce blood pressure

Read the 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® .
Conditions
Prehypertension
Being tested
KEFPEP®, Placebo
Medical subject headings
Prehypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KEFPEP®Dietary supplement

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

  • PlaceboOther

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

Study groups in NCT06393621
Study groupRoleWhat they receive
KEFPEP®Experimental1. 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.
Receives: Dietary Supplement: KEFPEP®
PlaceboPlacebo comparator1. Dosage form: Powder (directly take the powder with appropriate amount of warm water). 2. Dose(s): Total 2.8 g starch power.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of 5 mmHg SBP

    1. Reduction of 5 mmHg from Baseline in office SBP. II. Reduction of 5 mmHg from Baseline in 24-hour ambulatory SBP.

    Measured: At week 12

  2. Reduction of 10 mmHg SBP

    1. Reduction of 10 mmHg from Baseline in office SBP. II. Reduction of 10 mmHg from Baseline in 24-hour ambulatory SBP.

    Measured: At week 12

Secondary outcomes (6)

  1. Office SBP and diastolic blood pressure (DBP)

    Compare the change from Baseline in office SBP and DBP

    Measured: Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6)

  2. 24-hour ambulatory

    Compare the change from Baseline in 24-hour ambulatory SBP and 24-hour ambulatory DBP

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

  3. 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.

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

  4. 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.

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

  5. 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.)

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

  6. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2024
  2. Study start26 Jul 2018
  3. Primary completion18 Apr 2023
  4. Study completion28 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06393621
Sponsor's protocol ID
PHP1705H01
Other IDs
201707074MIPC
Status last verified
Apr 2024
First submitted
20 Mar 2024
Last updated
1 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 14656957

  • 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.

    PubMed 16305721

  • 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/

    PubMed 32208570

Questions about this trial

What is this clinical trial studying?

A study testing KEFPEP® in people with Prehypertension, run by National Chung Hsing University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of 5 mmHg SBP (time frame: At week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06393621, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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