An interventional study of KEFPEP® and Placebo in Prehypertension, sponsored by National Chung Hsing University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by National Chung Hsing University · Not applicable, Interventional, and Treatment
To assess the ability of KEFPEP® to reduce blood pressure
Primary objective-
Secondary objective-
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 46 is below the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →National Chung Hsing University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Patients with any of the following conditions within 6 months prior to study participation:
Patients with abnormalities in the following laboratory parameters within 2 weeks prior to Screening visit or during the screening period:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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®
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
Twice daily (one pack before breakfast and the other before dinner)
Twice daily (one pack before breakfast and the other before dinner)
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.
Time frame: 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.
Time frame: At week 12
Office SBP and diastolic blood pressure (DBP)
Compare the change from Baseline in office SBP and DBP
Time frame: Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6)
24-hour ambulatory
Compare the change from Baseline in 24-hour ambulatory SBP and 24-hour ambulatory DBP
Time frame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
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.
Time frame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
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.
Time frame: Baseline (Day 1/Visit 3) and Week 12 (Visit 6)
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.)
Time frame: The 2-week follow-up period once completing the 12-week dietary
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).
Time frame: The 2-week follow-up period once completing the 12-week dietary
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Apr 2023, 56 months.
Of 56 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 37. This study's 56 months is above that.
Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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National Chung Hsing University