Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise
Primary Purpose
Exercise Addiction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Gojinsen® drinks
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Addiction
Eligibility Criteria
Inclusion Criteria:
- healthy male and female adults aged 20-25 years old .
- without heart, liver, kidney, endocrine or other major organic diseases).
- had at least 3 months experience in performing exercise
Exclusion Criteria:
1. BMI of the study subjects must be less than 25.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Gojinsen® drinks
Arm Description
consume 1 sachet per day for 14 day
consume 1 sachet per day for 14 day
Outcomes
Primary Outcome Measures
Endurance exercise performance testing
the subjects arrived to the laboratory and wore the oxygen uptake mask of energy metabolism analyzer (Sensor Medics, Vmax29, USA) to measure the subjects' oxygen uptake
rating of perceived exertion
The Rated Perceived Exertion was measured during the treadmill exercise by Bruce Protocol, a gradual increase in the speed and the slope of the treadmill every 3 minutes.
blood lactate
fingertip capillary blood was placed in automated blood lactate analyzer
Continuous attention performance test
10 minutes after maximal exercise test, the subjects performed attention tests that used Canon continuous attention software
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05129917
Brief Title
Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise
Official Title
The Anti-fatigue Effect of Gojinsen® Drink
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
December 1, 2013 (Actual)
Study Completion Date
December 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of the present study is to determine the effects of acute and short-term (14 days) ginseng combined with branch chained amino acids supplementation on endurance exercise performance and the ability of anti-fatigue. In addition, this study also measured the performance of continuous attention during recovery period to examine the effect of supplementation on central fatigue.
Detailed Description
Muscle fatigue was a common problem after exercise. When fatigue occured, body functions were affected and changed. Changbai Mountain ginseng had higher anti-fatigue substances than general commercial ginseng. And recent studies had showed that the supplementation of branched chain amino acids (BCAA), including leucine, isoleucine and valine, can increase attention and reduce fatigue. However, its effect on Changbai Mountain ginseng combined with BCAA was still unclear. Subjects were allocated to Gojinsen® drinks and placebo group (1:1 ratio) for 14 days, and then examined by maximal oxygen consumption, time to exhaustion, rating of perceived exertion (RPE), oxygen saturation (SPO2) , blood lactate concentration, and continuous attention performance test (CPT II). The Gojinsen® group significant increased maximal oxygen consumption, time to exhaustion, and attention compared to placebo group. Moreover, the Gojinsen® group significant decreased lactate concentration and fatigue compared to placebo group. By this study, Gojinsen® drinks did not showed absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for people suffering from exercise fatigue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
consume 1 sachet per day for 14 day
Arm Title
Gojinsen® drinks
Arm Type
Experimental
Arm Description
consume 1 sachet per day for 14 day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
consume 1 sachet per day for 14 day
Intervention Type
Dietary Supplement
Intervention Name(s)
Gojinsen® drinks
Intervention Description
consume 1 sachet per day for 14 day
Primary Outcome Measure Information:
Title
Endurance exercise performance testing
Description
the subjects arrived to the laboratory and wore the oxygen uptake mask of energy metabolism analyzer (Sensor Medics, Vmax29, USA) to measure the subjects' oxygen uptake
Time Frame
Execution on the 14th day
Title
rating of perceived exertion
Description
The Rated Perceived Exertion was measured during the treadmill exercise by Bruce Protocol, a gradual increase in the speed and the slope of the treadmill every 3 minutes.
Time Frame
Execution on the 14th day
Title
blood lactate
Description
fingertip capillary blood was placed in automated blood lactate analyzer
Time Frame
Execution on the 14th day
Title
Continuous attention performance test
Description
10 minutes after maximal exercise test, the subjects performed attention tests that used Canon continuous attention software
Time Frame
Execution on the 14th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy male and female adults aged 20-25 years old .
without heart, liver, kidney, endocrine or other major organic diseases).
had at least 3 months experience in performing exercise
Exclusion Criteria:
1. BMI of the study subjects must be less than 25.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo han Wu, Ph.D
Organizational Affiliation
Pingtung University of Science and Technology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise
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