- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590713
Effect of Korean Ginseng Extract on Fatigue
Effect ofKorean Ginseng Extract on Fatigue
This study evaluated whether eight weeks of Korean ginseng extract supplementation could affect exercise performance, body composition, and selected blood-based physiological markers in healthy adults.
A total of 60 healthy adults aged 20 to 50 years were recruited and randomly assigned to either a Korean ginseng extract group or a placebo group in a double-blind, placebo-controlled design. Participants consumed one 10 mL packet of Korean ginseng extract or placebo daily for eight weeks. Assessments were performed before and after the intervention. Outcome measures included exercise performance tests, body composition, endocrine markers, inflammatory markers, oxidative stress markers, immune cell indices, and blood cell counts.
Forty-nine participants completed the post-intervention assessments. The study was approved by the University of Taipei Institutional Review Board under approval number IRB-2023-011.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 111
- Institute of Sports Sciences, University of Taipei
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults aged 20 to 50 years.
- Able and willing to participate in the study.
- Able to provide written informed consent.
Exclusion Criteria:
- Allergy to ginseng products.
- History of cardiovascular disease, asthma, diabetes, liver disease, kidney disease, arrhythmia, or other chronic diseases.
- Current use of medications for chronic diseases.
- Habitual use of ginseng or other traditional Chinese medicine-related supplements.
- Pregnancy or breastfeeding.
- Menopausal women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Korean Ginseng Extract Group
Participants received one 10 mL packet of Korean ginseng extract daily for eight weeks.
|
Korean ginseng extract supplement, provided as one 10 mL packet daily for eight weeks.
The supplement contained ginseng extract, water, and fructooligosaccharides.
|
|
Placebo Comparator: Placebo Group
Participants received one 10 mL packet of placebo daily for eight weeks.
The placebo was designed to have a similar taste and appearance to the Korean ginseng extract supplement.
|
Placebo supplement, provided as one 10 mL packet daily for eight weeks.
The placebo was designed to have a similar taste and appearance to the Korean ginseng extract supplement and contained water, maltodextrin, fructooligosaccharides, and casein phosphopeptide.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Biceps Strength
Time Frame: Baseline and 8 weeks
|
Change in biceps isokinetic strength from baseline to after eight weeks of supplementation, assessed using an isokinetic dynamometer.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in VO2max
Time Frame: Baseline and 8 weeks
|
Change in maximal oxygen uptake from baseline to after eight weeks of supplementation, assessed using a cycle ergometer and portable gas analysis system.
|
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2023-01l
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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