NCT04742244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

January 25, 2021

Last Update Submit

March 8, 2021

Conditions

Keywords

DOMS,Lemon verbena

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0 mg LVE/capsule, 2capsule/day, 14days

Dietary Supplement: maltodextrin

Lemon Verbena extract

EXPERIMENTAL

200 mg LVE/capsule, 2capsule/day, 14days

Dietary Supplement: Lvemon verbena extract

Interventions

Lvemon verbena extractDIETARY_SUPPLEMENT

Each capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days

Lemon Verbena extract
maltodextrinDIETARY_SUPPLEMENT

Each capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days

Placebo

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • health
  • Must be able to swallow tablets

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Sport University

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myalgia

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chi-Chang Huang, Ph.D

    PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 8, 2021

Study Start

May 28, 2020

Primary Completion

July 28, 2020

Study Completion

August 13, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations