Lemon Verbena Extract Oxidative Stress and Muscle Damage

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.

Study Overview

• Status: Completed
• Conditions: Muscle Soreness; Muscle Injury
• Intervention / Treatment: Dietary supplement: maltodextrin; Dietary supplement: Lvemon verbena extract

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • National Taiwan Sport University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; 0 mg LVE/capsule, 2capsule/day, 14days	Dietary supplement: maltodextrin; Each capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days
EXPERIMENTAL: Lemon Verbena extract; 200 mg LVE/capsule, 2capsule/day, 14days	Dietary supplement: Lvemon verbena extract; Each capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Taiwan Sport University
• Investigators: Principal Investigator: Chi-Chang Huang, Ph.D, PI

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2020
• Primary Completion (ACTUAL): July 28, 2020
• Study Completion (ACTUAL): August 13, 2020

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (ACTUAL): February 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: DOMS,; Lemon verbena
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: 00002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No