NCT03828188

Brief Summary

This study was conducted to investigate the effects of daily supplementation of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

January 30, 2019

Last Update Submit

May 7, 2020

Conditions

Hyperlipidemias

Keywords

Red Ginseng Concentrated PowderHyperlipidemiasClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Changes of Fasting triglyceride

    Changes of Fasting triglyceride was assessed before and after the intervention

    12 weeks

Secondary Outcomes (4)

  • Changes of Lipid metabolism indices

    30 weeks

  • Changes of Arteriosclerosis indices

    30 weeks

  • Changes of Carnitine (Serum)

    30 weeks

  • Changes of lipoprotein lipase

    30 weeks

Study Arms (2)

group A

EXPERIMENTAL

Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks. * Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) * Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)

Dietary Supplement: Red Ginseng Concentrated PowderDietary Supplement: Placebo

group B

EXPERIMENTAL

Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks. * Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day) * Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)

Dietary Supplement: Red Ginseng Concentrated PowderDietary Supplement: Placebo

Interventions

Red Ginseng Concentrated PowderDIETARY_SUPPLEMENT

Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.

group Agroup B
PlaceboDIETARY_SUPPLEMENT

Placebo for 12 weeks.

group Agroup B

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19-70 years with Triglyceride 120-200 mg/dL

You may not qualify if:

  • Lipid lowering agent within past 6 months
  • Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
  • Persons with significant hypersensitivity reactions to ginseng and red ginseng
  • Those with a history of gastrointestinal disorders (ex, Crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials
  • Those who have received antipsychotic medication within 2 months before screening
  • Those with a history of alcoholism or substance abuse
  • Those who participated in other clinical trials within 2 months before screening
  • Laboratory test by show the following results
  • Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  • Serum Creatinine \> 2.0 mg/dL
  • Pregnancy or breast feeding
  • Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
  • Principal Investigator judged inappropriate for participation in study because of 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

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 4, 2019

Study Start

March 1, 2018

Primary Completion

May 11, 2018

Study Completion

May 8, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

KR(1)