None listed
Conditions
Interventions
Dietary Supplement : 1) Product and Ingredients
• The powdered clinical trial product containing L. fermentum DM075 and the placebo are manufactured by VITECH Co., Ltd.
• To maintain identical taste a
Sponsors
Apple Tree Medical Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults aged 20 years or older and under 70 years • Those whose average systolic blood pressure measured twice at 2-minute intervals after resting for at least 5 minutes in a seated position is within the range of 125-145 mmHg, or whose diastolic blood pressure is within the range of 80-95 mmHg (However, if falling within stage 1 hypertension range (systolic blood pressure: 140-145 mmHg or diastolic blood pressure: 90-95 mmHg), those determined by the principal investigator to require medication will be excluded.) • Those who have been fully informed about this study, completely understand it, voluntarily decide to participate, and provide written consent to comply with the precautions
Exclusion criteria
Exclusion criteria: • Smokers (Former smokers who have quit for at least 6 months may be included) • Those who have taken antibiotics within 1 month prior to the trial start date • Those who have taken antihypertensive drugs, blood circulation improvers (ginkgo leaf extract, aspirin, etc.), or related health functional foods within 1 month prior to the trial start date • Those who have taken medications that may affect blood pressure other than antihypertensive drugs and blood circulation improvers (beta blockers, alpha blockers for treating benign prostatic hyperplasia, etc.) within 1 month prior to the trial start date • Those who have taken functional foods containing peptide components within 1 month prior to the trial start date • Those who have taken herbal medicine within 1 month prior to the trial start date • Those who are currently in treatment for alcohol addiction or thyroid dysfunction, or have been within 3 months prior to the trial start date • Those who have taken oral steroids, hormone drugs, etc., within 1 month prior to the trial start date • Those with heart disease (coronary artery disease, heart failure, angina, myocardial infarction, etc.), stroke, brain tumor, or malignant tumor • Diabetic patients currently taking medication • Those who have undergone surgery within 6 months prior to the trial start date • Those with severe kidney or liver dysfunction (serum creatinine > 2 times the maximum normal value, ALT, AST, alkaline phosphatase > 3 times the maximum normal value) • Those with platelet count (below 150,000/mm³), white blood cell count (below 3,000/mm³), or hemoglobin levels (below 9.5g/dL for men, 9.0g/dL for women) • Those who have undergone surgeries that may affect drug absorption, such as gastrectomy • Pregnant women, nursing mothers, and women of childbearing potential who do not use appropriate contraception • Those who have taken other clinical trial foods or drugs within 3 months prior to the trial start date (participants in medical device clinical trials can participate without a washout period) • Those who have donated blood within 2 months prior to the trial start date or component blood within 1 month • Those who, in the opinion of the principal investigator, cannot comply with the requirements of the trial or are deemed unsuitable for this clinical trial • Patients with uncontrolled hypertension (160/100mmHg or higher, or those who have been taking new medications for hypertension within the past 3 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical mean SBP;Clinical mean DBP | — |
Secondary
| Measure | Time frame |
|---|---|
| average arterial pressure at office;average pulse at office;hs-CRP;self (home) blood pressure measurement systolic pressure;self (home) blood pressure measurement diastolic pressure | — |
Countries
Korea, Republic of
Contacts
Public ContactMu-Yeol Cho
Apple Tree Medical Foundation
Outcome results
None listed