Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow

12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow

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.

Study Overview

• Status: Unknown
• Conditions: Blood Flow
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Recruiting
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Improvement of Blood Flow group; 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)	Dietary supplement: Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures; One packet once a day, after breakfast, for 12 week
Placebo Comparator: Placebo group; One packet once a day, after breakfast (1.5 g/day)	Dietary supplement: Placebo; Placebo for 12 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Platelet function assay(PFA)	The concentration of Platelet function assay(PFA) was assessed before and after the intervention	Baseline, 12 week
Changes of blood viscosity	The concentration of blood viscosity was assessed before and after the intervention	Baseline, 12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse	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).	screening, 0 week, 6 week, 12 week
Changes of blood coagulation-related indices	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).	Baseline, 12 week
Changes of indicator of lipid metabolism	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).	Baseline, 12 week
Changes of atherosclerosis index	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).	Baseline, 12 week

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HJ-BF-AAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No