Sports Physical TherapyEarly Phase 1GinsengRunNCT03888196
Evaluation of the Efficacy of Panax Ginseng on Lipid Metabolism in Men and the Relationship With Sports Practice.
A Early Phase 1 study testing Panax Ginseng Supplementation in people with Sports Physical Therapy, run by Universitat de Lleida.
Trial summary
Panax Ginseng (P ginseng), C.A. Meyer, Red, Chinese or Korean ginseng is a plant from eastern Asia and is one of the most widely used herbal products in the world. P ginseng has been been used for many years for different medical therapies. Previous studies have demonstrate that P. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Panax Ginseng Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 15 Jan 2019
- Phase
- Early Phase 1
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Athletic men of aerobic type, who participate in a supervised training as a previous step to the accomplishment of competitions
- Which their age is older than 18 years
- Training superior or equal to 3 days per week and that these workouts are stable during the intervention.
Who cannot join
- Athletes with high blood pressure, with pharmacological treatment for hypercholesterolemia, diabetes, any psychiatric illness
- Athletes who practice sports without having the objective of increasing sports performance
- Athletes who use some type of ergogenic sport supplementation looking to optimize any aspect related to the sport.
About this study
Panax Ginseng (P ginseng), C.A. Meyer, Red, Chinese or Korean ginseng is a plant from eastern Asia and is one of the most widely used herbal products in the world. P ginseng has been been used for many years for different medical therapies. Previous studies have demonstrate that P. ginseng root extract supplementation may promote fat oxidation, increase hepatic glycogen levels and produce a glycogen-sparing and antifatigue effect during exercise in swimming rats. Notwithstanding, although there is some evidence of P. ginseng effects in humans, no evidence has been obtained respect to its supplementation in human sport performance. The aim of this study is to assess the effect of P ginseng extract supplementation on the lipid metabolism and sport performance in male endurance runners. For this purpose, the effect of supplementation for 2 weeks of 500 mg/day of P. ginseng will be evaluated in a sub-maximal physical stress test. Variables of lipid metabolism, energy consumption, fatigue, and endurance will be determined.
- Conditions
- Sports Physical Therapy
- Being tested
- Panax Ginseng Supplementation, Placebo Supplementation
- Keywords
- Panax, Lipid Metabolism, Sport Performance, Running, Ginseng
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panax Ginseng SupplementationDietary supplement
500 mg/day of Panax Ginseng
Placebo SupplementationDietary supplement
500 mg/day of Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 500 mg/day of Panax Ginseng. 2 weeks treatment Receives: Dietary Supplement: Panax Ginseng Supplementation |
| Control Group | Placebo comparator | 500 mg/day of Celulose. 2 weeks treatment Receives: Dietary Supplement: Placebo Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline plasmatic Total Lipids at 2 weeks
Total Lipids in the plasma are measured in mg / dL
Measured: 2 weeks
Change from baseline plasmatic Triglycerides at 2 weeks
Triglycerides in the plasma are measured in mg / dL
Measured: 2 weeks
Change from baseline Respiratory Exchange Rate at 2 weeks
To quantify the amount of Oxygen consumed and the amount of carbon dioxide produced. (mL/Kg/Min)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Sep 2016
- Primary completion1 Nov 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Serrano, Universitat de Lleida
- Investigators
- Jose D Serrano, Dr, Study chair, Universitat de LleidaAlba Naudí, Dra, Study director, Universitat de LleidaCristian D Hernandez, PhD Student, Principal investigator, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888196
- Sponsor's protocol ID
- Nutren-Disanta 0012018
- Acronym
- GinsengRun
- Status last verified
- Apr 2019
- First submitted
- 21 Mar 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Panax Ginseng on Lipid Metabolism in Men and the Relationship With Sports Practice.
- ClinicalTrials.gov ID
- NCT03888196
- Acronym / sponsor ID
- GinsengRun / Nutren-Disanta 0012018
- Conditions
- Sports Physical Therapy
- Keywords
- Panax, Lipid Metabolism, Sport Performance, Running, Ginseng
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 25 Mar 2019 (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.
Panax Ginseng (P ginseng), C.A. Meyer, Red, Chinese or Korean ginseng is a plant from eastern Asia and is one of the most widely used herbal products in the world. P ginseng has been been used for many years for different medical therapies. Previous studies have demonstrate that P. ginseng root extract supplementation may promote fat oxidation, increase hepatic glycogen levels and produce a glycogen-sparing and antifatigue effect during exercise in swimming rats. Notwithstanding, although there is some evidence of P. ginseng effects in humans, no evidence has been obtained respect to its supplementation in human sport performance. The aim of this study is to assess the effect of P ginseng extract supplementation on the lipid metabolism and sport performance in male endurance runners. For this purpose, the effect of supplementation for 2 weeks of 500 mg/day of P. ginseng will be evaluated in a sub-maximal physical stress test. Variables of lipid metabolism, energy consumption, fatigue, and endurance will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Panax Ginseng Supplementation500 mg/day of Panax Ginseng. 2 weeks treatment |
| Control Group | Placebo comparator | Dietary Supplement: Placebo Supplementation500 mg/day of Celulose. 2 weeks treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Athletic men of aerobic type, who participate in a supervised training as a previous step to the accomplishment of competitions
- Which their age is older than 18 years
- Training superior or equal to 3 days per week and that these workouts are stable during the intervention.
Key exclusion criteria (3 listed)
- Athletes with high blood pressure, with pharmacological treatment for hypercholesterolemia, diabetes, any psychiatric illness
- Athletes who practice sports without having the objective of increasing sports performance
- Athletes who use some type of ergogenic sport supplementation looking to optimize any aspect related to the sport.
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 |
|---|---|---|
| Panax Ginseng Supplementation500 mg/day of Panax Ginseng | Dietary supplement | Intervention Group |
| Placebo Supplementation500 mg/day of Cellulose | Dietary supplement | Control Group |
Primary outcome
Change from baseline plasmatic Total Lipids at 2 weeks
Time frame: 2 weeks
Total Lipids in the plasma are measured in mg / dL
Change from baseline plasmatic Triglycerides at 2 weeks
Time frame: 2 weeks
Triglycerides in the plasma are measured in mg / dL
Change from baseline Respiratory Exchange Rate at 2 weeks
Time frame: 2 weeks
To quantify the amount of Oxygen consumed and the amount of carbon dioxide produced. (mL/Kg/Min)
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 2 May 2019.
- Individual participant dataSharing planned: No
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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.
Jose D Serrano, Dr study chair
Universitat de Lleida
Alba Naudí, Dra study director
Universitat de Lleida
Cristian D Hernandez, PhD Student principal investigator
Universitat de Lleida
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Panax Ginseng Supplementation in people with Sports Physical Therapy, run by Universitat de Lleida.
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 3 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 2 May 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline plasmatic Total Lipids at 2 weeks (time frame: 2 weeks). The study lists 3 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 2 May 2019.