Muscle InjuryNCT04742244
Lemon Verbena Extract Oxidative Stress and Muscle Damage
A study testing Lvemon verbena extract and maltodextrin in people with Muscle Injury and Muscle Soreness, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
In the present study, investigators investigated whether supplementation with lemon verbena extract (LVE) could improve muscle damage and biochemical indicators after exhaustive exercise challenge. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury, Muscle Soreness
- What is being tested?
- Lvemon verbena extract and maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 May 2020to 13 Aug 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- health
- Must be able to swallow tablets
Who cannot join
- non-smokers
- no musculoskeletal
- medical
- metabolic disease
- women not on the reproductive cycle
- high blood pressure, asthma
- skeletal neuromuscular injuries in the upper or lower extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Supplementation With Lemon Verbena Extract in Improving
In the present study, investigators investigated whether supplementation with lemon verbena extract (LVE) could improve muscle damage and biochemical indicators after exhaustive exercise challenge. Based on maximum jump heights, 60 subjects (30 males and 30 females) were equally divided into a placebo group (0 mg/human/day) and an LVE supplement group (400 mg/human/day), with gender-equal distribution. All subjects started supplementation 10 days before exhaustive exercise and continued it until all tests were completed. Before the intervention, after the exhaustive exercise, and on the following 3 days, the participants underwent 12-minute Cooper running/walking; blood collection; assessments of pain, muscle stiffness, maximum jump heights, and isometric maximum muscle strength; and anaerobic strength tests.
- Conditions
- Muscle Injury, Muscle Soreness
- Being tested
- Lvemon verbena extract, maltodextrin
- Keywords
- DOMS,, Lemon verbena
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lvemon verbena extractDietary supplement
Each capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days
maltodextrinDietary supplement
Each capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0 mg LVE/capsule, 2capsule/day, 14days Receives: Dietary Supplement: maltodextrin |
| Lemon Verbena extract | Experimental | 200 mg LVE/capsule, 2capsule/day, 14days Receives: Dietary Supplement: Lvemon verbena extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammation of IL-6 level
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, including baseline (0) and 3h, 24h, and 48 after exercise, blood samples were collected with brachial venous catheters. Assess serum IL-6 levels (pg/ml) to monitor physiological fitness. Used commercial kit human IL-6 immunoassay (R\&D system, Minnesota, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: 10 days
Clinical Biochemistry of CK level
To assess muscle damage, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, including baseline (0) and 3h, 24h, and 48 after exercise, blood samples were collected with brachial venous catheters. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
Measured: 10 days
Stress hormones 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) in Urine
Subjects' urine was collected 24 hours after the exhaustive exercise for analysis. Used commercial kit human 8-OHdG (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Measured: 10 days
Assessment of muscle stiffness
3 h, 24h, 48h after exhausting exercise, use Myoton machine to evaluate muscle stiffness (N/m) (Myoton, Tallinn, Estonia)
Measured: 10 days
Visual Analogue Scale (VAS) evaluation
3 h, 24h, 48h after exhausting exercise, use VAS questionnaire to record muscle pain. the minimum is 0 and maximum is 10, and whether higher scores mean more pain
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start28 May 2020
- Primary completion28 Jul 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle InjuryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Chang Huang, National Taiwan Sport University
- Investigators
- Chi-Chang Huang, Ph.D, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742244
- Sponsor's protocol ID
- 00002
- Status last verified
- Mar 2021
- First submitted
- 25 Jan 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee MC, Hsu YJ, Ho CS, Chang CH, Liu CW, Huang CC, Chiang WD. Evaluation of the Efficacy of Supplementation with Planox(R) Lemon Verbena Extract in Improving Oxidative Stress and Muscle Damage: A Randomized Double-Blind Controlled Trial. Int J Med Sci. 2021 May 3;18(12):2641-2652. doi: 10.7150/ijms.60726. eCollection 2021.
PubMed 34104096
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Supplementation With Lemon Verbena Extract in Improving
- ClinicalTrials.gov ID
- NCT04742244
- Acronym / sponsor ID
- 00002
- Conditions
- Muscle Injury, Muscle Soreness
- Keywords
- DOMS,, Lemon verbena
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 28 May 2020 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 8 Feb 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.
In the present study, investigators investigated whether supplementation with lemon verbena extract (LVE) could improve muscle damage and biochemical indicators after exhaustive exercise challenge. Based on maximum jump heights, 60 subjects (30 males and 30 females) were equally divided into a placebo group (0 mg/human/day) and an LVE supplement group (400 mg/human/day), with gender-equal distribution. All subjects started supplementation 10 days before exhaustive exercise and continued it until all tests were completed. Before the intervention, after the exhaustive exercise, and on the following 3 days, the participants underwent 12-minute Cooper running/walking; blood collection; assessments of pain, muscle stiffness, maximum jump heights, and isometric maximum muscle strength; and anaerobic strength tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: maltodextrin0 mg LVE/capsule, 2capsule/day, 14days |
| Lemon Verbena extract | Experimental | Dietary Supplement: Lvemon verbena extract200 mg LVE/capsule, 2capsule/day, 14days |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- health
- Must be able to swallow tablets
Key exclusion criteria (7 listed)
- non-smokers
- no musculoskeletal
- medical
- metabolic disease
- women not on the reproductive cycle
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 |
|---|---|---|
| Lvemon verbena extractEach capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days | Dietary supplement | Lemon Verbena extract |
| maltodextrinEach capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days | Dietary supplement | Placebo |
Primary outcome
inflammation of IL-6 level
Time frame: 10 days
To assess inflammation indicators, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, including baseline (0) and 3h, 24h, and 48 after exercise, blood samples were collected with brachial venous catheters. Assess serum IL-6 levels (pg/ml) to monitor physiological fitness. Used commercial kit human IL-6 immunoassay (R\&D system, Minnesota, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Clinical Biochemistry of CK level
Time frame: 10 days
To assess muscle damage, volunteers fasted for at least 8 hours before performing muscle exhaustion exercises. At designated time points in the recovery period, including baseline (0) and 3h, 24h, and 48 after exercise, blood samples were collected with brachial venous catheters. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
Stress hormones 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) in Urine
Time frame: 10 days
Subjects' urine was collected 24 hours after the exhaustive exercise for analysis. Used commercial kit human 8-OHdG (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis
Assessment of muscle stiffness
Time frame: 10 days
3 h, 24h, 48h after exhausting exercise, use Myoton machine to evaluate muscle stiffness (N/m) (Myoton, Tallinn, Estonia)
Visual Analogue Scale (VAS) evaluation
Time frame: 10 days
3 h, 24h, 48h after exhausting exercise, use VAS questionnaire to record muscle pain. the minimum is 0 and maximum is 10, and whether higher scores mean more pain
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 10 Mar 2021.
- Derived from this study: PubMed 34104096Lee MC, Hsu YJ, Ho CS, Chang CH, Liu CW, Huang CC, Chiang WD. Evaluation of the Efficacy of Supplementation with Planox(R) Lemon Verbena Extract in Improving Oxidative Stress and Muscle Damage: A Randomized Double-Blind Controlled Trial. Int J Med Sci. 2021 May 3;18(12):2641-2652. doi: 10.7150/ijms.60726. eCollection 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.
Chi-Chang Huang, Ph.D principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lvemon verbena extract and maltodextrin in people with Muscle Injury and Muscle Soreness, run by National Taiwan Sport University at 1 site in Taiwan.
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 2 inclusion and 7 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
inflammation of IL-6 level (time frame: 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742244, which also lists 1 linked publication.
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 10 Mar 2021.