Efficacy and Safety of ABF on Blood Flow Improvement; A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0005912
• Lead Sponsor: JBKLAB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Adult men and women who aged 25 to 70
2. Those who meet at least three items under the following conditions(Screening visit)
1) A person with 200 to 239 mg/dL of Total Cholesterol on empty stomach
2) A person with 130 to 159 mg/dL of LDL-Cholesterol on empty stomach
3) A person with 100 to 125 mg/dL of Blood sugar on empty stomach
4) A person with 120 to 139 mmHg of Systolic blood pressure
5) A person whose BMI is not less than 25 kg/? and not more than 30 kg/?
6) Persons with waist/hip circumference (WHR) greater than 0.9 for males and 0.85 for females
3. A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.

Exclusion Criteria

1. Those who are currently being treated with severe cardiovascular, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious disease, and malignant tumor (However, in the case of subjects who are clinically stable, considering subject's condition, can participate in the clinical trial at the discretion of the tester.)
2. Those who have used Anticoagulants (warfarin, etc.), antiplatelet agents (aspirin, clopidogrel, etc.), calcium antagonists, beta-blockers, hormone agents (oral and injection drugs such as dexamethasone, betamethasone, somatropine, lutropine alpha), diabetes medication (oral and injection drugs) within 2 weeks of screening visit
3. Those who have consumed health functional foods that may affect blood flow such as red ginseng, ginseng, natto, guava leaf extract, indigestible maltodextrin, etc. within 2 weeks of screening visit
4. Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects)
5. Uncontrolled diabetic persons (fasting blood sugar of 180 mg/dL or higher)
6. Those whose TSH is not more than 0.1 µIU/mL or greater than 10 µIU/mL
7. Those whose Creatinine is more than twice the normal upper limit of the study institution
8. Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution
9. Those who have operation history within 3 months of screening visit
10. Those who have been medicated hyperlipidemia drug newly within 3 months of screening visit
11. Those who complains of severe gastrointestinal symptoms, such as heartburn or indigestion
12. Persons who are sensitive to or allergic to investigational product ingredients for this clinical trial
13. Persons who are pregnant or who are lactating women or who have a plan to conceive during this clinical trial period
14. Those who participated in other clinical trials within 3 months of screening visit, or who plan to participate in other clinical trials after the start of this clinical trial
15. A person who determines that the Investigator is inappropriate for clinical trials

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
platelet aggregability;PAT Index(Peripheral Arterial Tonometry Index);MDA(Malondialdehyde), Oxidized LDL(Oxidized Low Density Lipoprotein);Total Cholesterol, Triglyceride, HDL-Cholesterol(High Density Lipoprotein-Cholesterol), LDL-Cholesterol(Low Density Lipoprotein-Cholesterol);Thromboxane B2, eNOS(endothelial Nitric Oxide Synthase), COX-2(Cyclooxygenase-2);PT(Prothrombin Time), aPTT(activated Partial Thromboplastin Time);blood pressure