NCT04389125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

April 29, 2020

Last Update Submit

May 11, 2020

Conditions

Blood Flow

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Changes of systolic blood pressure(SBP), diastolic blood pressure(DBP), Pulse

    screening, 0 week, 6 week, 12 week

  • Changes of blood coagulation-related indices

    Baseline, 12 week

  • Changes of indicator of lipid metabolism

    Baseline, 12 week

  • Changes of atherosclerosis index

    Baseline, 12 week

Study Arms (2)

Improvement of Blood Flow group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

One packet once a day, after breakfast (1.5 g/day)

Dietary Supplement: Placebo

Interventions

Angelica Gigas Nakai and Allium Cepa L.Extract MixturesDIETARY_SUPPLEMENT

One packet once a day, after breakfast, for 12 week

Improvement of Blood Flow group
PlaceboDIETARY_SUPPLEMENT

Placebo for 12 week

Placebo group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Central Study Contacts

Soo Wan Chae, Ph.D., M.D.

CONTACT

82-63-259-3040soowan@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 15, 2020

Study Start

January 30, 2020

Primary Completion

April 30, 2021

Study Completion

May 30, 2021

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

KR(1)