Blood Flow
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAngelica Gigas Nakai and Allium Cepa L.Extract Mixtures
One packet once a day, after breakfast, for 12 week
DIETARY_SUPPLEMENTPlacebo
Placebo for 12 week
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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). |
Countries
South Korea
Contacts
Primary ContactSoo Wan Chae, Ph.D., M.D.
Outcome results
None listed