Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow
- Conditions
- Blood Flow
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures
- Registration Number
- NCT04389125
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
This study was conducted to investigate the effects of daily supplementation of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow.
- Detailed Description
This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures once a day, in comparison with taking a placebo.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Participants who meet three or more items
- Smoker
- Total cholesterol 180~239 mg/dL before a meal
- LDL cholesterol 130~159 mg/dL before a meal
- Glucose 100~125 mg/dL before a meal
- systolic blood pressure(SBP) is 120~140 mmHg
- Body mass index(BMI) is 23~30 kg/m^2
- Waist/Hip ratio(WHR) is 0.9 over for man, 0.85 over for a woman
- Participants with marked impairment of platelet function and platelet coagulation
- Participants who have anticoagulation within 4 weeks before the screening test
- Participants with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, Inflammation, blood tumor, gastric disease, etc.
- Participants with BMI(Body mass index) less than 18.5 kg/m^2 or more than 35 kg/m^2 at the screening test
- Participants who take medicine or healthy functional foods for platelet function, blood circulation improvement, and hyperlipidemia within 4 weeks before the screening test
- Participants receiving antipsychotic medication within 3 months prior to the screening test
- Participants suspected of alcoholism(21 unit/week) or substance abuse
- Participants who have participated in other clinical trials within 3 months prior to the screening test
- Participants who show the following relevant results in a Laboratory test º Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit º Serum Creatinine > 2.0 mg/dl
- Women who are pregnant or breastfeeding
- Women who may become pregnant and have not used appropriate contraceptives
- Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo One packet once a day, after breakfast (1.5 g/day) Improvement of Blood Flow group Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures One packet once a day, after breakfast (1.5 g/day, 1.5 g/day as an Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures)
- Primary Outcome Measures
Name Time Method Changes of Platelet function assay(PFA) Baseline, 12 week The concentration of Platelet function assay(PFA) was assessed before and after the intervention
Changes of blood viscosity Baseline, 12 week The concentration of blood viscosity was assessed before and after the intervention
- Secondary Outcome Measures
Name Time Method Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse screening, 0 week, 6 week, 12 week systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse were measured in study screening, visit 1(0 week), visit 2(6 weeks) and visit 3(12 weeks).
Changes of indicator of lipid metabolism Baseline, 12 week Lipid metabolism(e.g. Total cholesterol, Triglyceride, Low Density Lipoprotein-cholesterol, High Density Lipoprotein-cholesterol, Non High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 weeks).
Changes of blood coagulation-related indices Baseline, 12 week Blood coagulation-related indices(e.g. Plasminogen activator inhibitor-1, Serotonin, Thromboxane B2, activated partial thromboplastin time) were measured in study visit 1(0 week) and visit 3(12 weeks).
Changes of atherosclerosis index Baseline, 12 week Atherosclerosis index(e.g. Total cholesterol/High Density Lipoprotein-cholesterol, Low Density Lipoprotein-cholesterol/High Density Lipoprotein-cholesterol, Triglyceride/High Density Lipoprotein-cholesterol, (Total cholesterol-High Density Lipoprotein-cholesterol)/High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 weeks).
Trial Locations
- Locations (1)
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of