Lemon Verbena Extract Oxidative Stress and Muscle Damage
Primary Purpose
Muscle Injury, Muscle Soreness
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lvemon verbena extract
maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Injury focused on measuring DOMS,, Lemon verbena
Eligibility Criteria
Inclusion Criteria:
- health
- Must be able to swallow tablets
Exclusion Criteria:
- 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
Sites / Locations
- National Taiwan Sport University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Lemon Verbena extract
Arm Description
0 mg LVE/capsule, 2capsule/day, 14days
200 mg LVE/capsule, 2capsule/day, 14days
Outcomes
Primary Outcome Measures
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
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).
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
Assessment of muscle stiffness
3 h, 24h, 48h after exhausting exercise, use Myoton machine to evaluate muscle stiffness (N/m) (Myoton, Tallinn, Estonia)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04742244
First Posted
January 25, 2021
Last Updated
March 8, 2021
Sponsor
National Taiwan Sport University
1. Study Identification
Unique Protocol Identification Number
NCT04742244
Brief Title
Lemon Verbena Extract Oxidative Stress and Muscle Damage
Official Title
Evaluation of the Efficacy of Supplementation With Lemon Verbena Extract in Improving
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan Sport University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injury, Muscle Soreness
Keywords
DOMS,, Lemon verbena
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0 mg LVE/capsule, 2capsule/day, 14days
Arm Title
Lemon Verbena extract
Arm Type
Experimental
Arm Description
200 mg LVE/capsule, 2capsule/day, 14days
Intervention Type
Dietary Supplement
Intervention Name(s)
Lvemon verbena extract
Intervention Description
Each capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Intervention Description
Each capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days
Primary Outcome Measure Information:
Title
inflammation of IL-6 level
Description
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
Time Frame
10 days
Title
Clinical Biochemistry of CK level
Description
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).
Time Frame
10 days
Title
Stress hormones 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) in Urine
Description
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
Time Frame
10 days
Title
Assessment of muscle stiffness
Description
3 h, 24h, 48h after exhausting exercise, use Myoton machine to evaluate muscle stiffness (N/m) (Myoton, Tallinn, Estonia)
Time Frame
10 days
Title
Visual Analogue Scale (VAS) evaluation
Description
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
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
health
Must be able to swallow tablets
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Chang Huang, Ph.D
Organizational Affiliation
PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Sport University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
34104096
Citation
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.
Results Reference
derived
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Lemon Verbena Extract Oxidative Stress and Muscle Damage
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