Exercise AddictionNCT05129917
Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise
A study testing Gojinsen® drinks in people with Exercise Addiction, run by TCI Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Addiction
- What is being tested?
- Gojinsen® drinks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 1. BMI of the study subjects must be less than 25.
About this study
Official title: The Anti-fatigue Effect of Gojinsen® Drink
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.
Read the 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.
- Conditions
- Exercise Addiction
- Being tested
- Placebo, Gojinsen® drinks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
consume 1 sachet per day for 14 day
Gojinsen® drinksDietary supplement
consume 1 sachet per day for 14 day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | consume 1 sachet per day for 14 day Receives: Dietary Supplement: Placebo |
| Gojinsen® drinks | Experimental | consume 1 sachet per day for 14 day Receives: Dietary Supplement: Gojinsen® drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Execution on the 14th day
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.
Measured: Execution on the 14th day
blood lactate
fingertip capillary blood was placed in automated blood lactate analyzer
Measured: Execution on the 14th day
Continuous attention performance test
10 minutes after maximal exercise test, the subjects performed attention tests that used Canon continuous attention software
Measured: Execution on the 14th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Jun 2013
- Primary completion1 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo han Wu, Ph.D, Principal investigator, Pingtung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129917
- Sponsor's protocol ID
- TSMH No.13-023-A2
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anti-fatigue Effect of Gojinsen® Drink
- ClinicalTrials.gov ID
- NCT05129917
- Acronym / sponsor ID
- TSMH No.13-023-A2
- Conditions
- Exercise Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboconsume 1 sachet per day for 14 day |
| Gojinsen® drinks | Experimental | Dietary Supplement: Gojinsen® drinksconsume 1 sachet per day for 14 day |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. BMI of the study subjects must be less than 25.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboconsume 1 sachet per day for 14 day | Dietary supplement | Placebo |
| Gojinsen® drinksconsume 1 sachet per day for 14 day | Dietary supplement | Gojinsen® drinks |
Primary outcome
Endurance exercise performance testing
Time frame: Execution on the 14th day
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
Time frame: Execution on the 14th day
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
Time frame: Execution on the 14th day
fingertip capillary blood was placed in automated blood lactate analyzer
Continuous attention performance test
Time frame: Execution on the 14th day
10 minutes after maximal exercise test, the subjects performed attention tests that used Canon continuous attention software
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo han Wu, Ph.D principal investigator
Pingtung University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Gojinsen® drinks in people with Exercise Addiction, run by TCI Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance exercise performance testing (time frame: Execution on the 14th day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.