Lemon Verbena Extract Oxidative Stress and Muscle Damage

Muscle Soreness Clinical Trial

Official title:

Evaluation of the Efficacy of Supplementation With Lemon Verbena Extract in Improving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742244
• Other study ID #: 00002
• Status: Completed
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: August 13, 2020

Study information

• Verified date: March 2021
• Source: National Taiwan Sport University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 13, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Injury
• Muscle Soreness
• Myalgia

Intervention

Dietary Supplement:
• Lvemon verbena extract
Each capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days
• maltodextrin
Each capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days

Locations

Country	Name	City	State
Taiwan	National Taiwan Sport University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan Sport University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 days
Primary	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).	10 days
Primary	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	10 days
Primary	Assessment of muscle stiffness	3 h, 24h, 48h after exhausting exercise, use Myoton machine to evaluate muscle stiffness (N/m) (Myoton, Tallinn, Estonia)	10 days
Primary	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	10 days