Effect of American Ginseng on Exercise-induced Muscle Soreness
Primary Purpose
Muscle Damage
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Ginseng
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Damage focused on measuring Muscle, Soreness, Muscle function, Damage, Ginseng
Eligibility Criteria
Inclusion Criteria:
- Healthy men or women, (women must weigh between 55-65 kg., while men must weigh between 75-85kg).
- Participants must not have engaged in any endurance run training in the past 9 months.
Exclusion Criteria:
- Injured
- Regular runners
- Pregnant (or with any chance they may become pregnant)
- Breast-feeding
- Diabetics or those taking medication for diabetes
- Insomniacs
- Schizophrenics
- Hyper- or hypotension
- Cancer
- Irregular heartbeats
- Heart disease
- Females with endometriosis or uterine fibroids
- Those who have surgery scheduled during the study or within the two weeks following the completion of the study
- Those taking warfarin or medication for depression.
Sites / Locations
- University of Western Ontario
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placeobo
Arm Description
American Ginseng ingestion
non-active ingredient
Outcomes
Primary Outcome Measures
muscle strength
ginseng & muscle strength
Secondary Outcome Measures
Full Information
NCT ID
NCT01827696
First Posted
April 4, 2013
Last Updated
March 1, 2016
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01827696
Brief Title
Effect of American Ginseng on Exercise-induced Muscle Soreness
Official Title
Effect of American Ginseng on Exercise-induced Muscle Soreness
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Healthy participants will ingest American ginseng daily or a placebo for four weeks prior to engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness. Muscle soreness will be assessed via decrements in muscle strength and with a self-rating of perceived soreness before and several times after the exercise.
Detailed Description
Healthy men and women will consume either 2000 mg of American ginseng daily (four 500 mg pills will be taken at four different times during the day always with food/meals) or a placebo (4 cellulose) for four weeks prior to engaging in a 40 minute downhill treadmill jog (12% decline) at a speed of 7 miles per hour. Participants will consume one pill with breakfast, one pill with lunch, one pill with dinner and another pill with a snack either between meals or prior to bedtime. The exercise will be consist of five, eight minute bouts of jogging with two minutes of rest/recovery in between. The degree of muscle soreness will be assessed using a Biodex strength testing machine (isometric and concentric isokinetic torque), and a self-rating of perceived soreness on a scale from zero to ten. All of the above measures will be taken before and several times after the downhill jogging protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Damage
Keywords
Muscle, Soreness, Muscle function, Damage, Ginseng
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
American Ginseng ingestion
Arm Title
Placeobo
Arm Type
Placebo Comparator
Arm Description
non-active ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginseng
Intervention Description
Effect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise
Primary Outcome Measure Information:
Title
muscle strength
Description
ginseng & muscle strength
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men or women, (women must weigh between 55-65 kg., while men must weigh between 75-85kg).
Participants must not have engaged in any endurance run training in the past 9 months.
Exclusion Criteria:
Injured
Regular runners
Pregnant (or with any chance they may become pregnant)
Breast-feeding
Diabetics or those taking medication for diabetes
Insomniacs
Schizophrenics
Hyper- or hypotension
Cancer
Irregular heartbeats
Heart disease
Females with endometriosis or uterine fibroids
Those who have surgery scheduled during the study or within the two weeks following the completion of the study
Those taking warfarin or medication for depression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter WR Lemon, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21598413
Citation
Jung HL, Kwak HE, Kim SS, Kim YC, Lee CD, Byurn HK, Kang HY. Effects of Panax ginseng supplementation on muscle damage and inflammation after uphill treadmill running in humans. Am J Chin Med. 2011;39(3):441-50. doi: 10.1142/S0192415X11008944.
Results Reference
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Effect of American Ginseng on Exercise-induced Muscle Soreness
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