- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028454
Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
December 18, 2017 updated by: Patrick Wilson, PhD, Old Dominion University
The objective of the study is to determine whether five days of ginger (Zingiber officinale) supplementation is effective at reducing muscle soreness and improving muscle function following downhill running.
Long-distance running is often associated with acute muscle pain, swelling, and reduced muscle functioning, and consequently, many runners utilize non-steroidal anti-inflammatory drugs (NSAID).
NSAID use is associated with gastrointestinal side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and symptomatic ulcers that, although rare, can be fatal.
Ginger is a botanical compound that is Generally Recognized as Safe by the Food and Drug Administration (FDA).
Evidence from osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is effective at reducing general pain and muscle soreness.
Therefore, this study will supplement 60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day of, and 2 days after downhill running.
Participants will be evaluated for muscle soreness and function before and after the downhill run.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Norfolk, Virginia, United States, 23529
- Human Performance Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be currently running ≥10 miles per week
- Have completed at least one run >40 minutes over the past month
Exclusion Criteria:
- Have no allergies to ginger
- Willing to avoid pain-relieving medications for the duration of the study
- Have no history of bleeding disorders nor currently taking blood thinners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Placebo Capsule
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Capsules containing rice flour powder.
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EXPERIMENTAL: Ginger Root Capsule
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Capsules containing 250 mg of ginger root extract standardized to contain at least 5% gingerol compounds, as well as an additional 225 mg of regular ginger root.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Soreness Change
Time Frame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, 24 hours after a 40-minute downhill run and the two days after a 40-minute downhill run
|
Participants will be asked to mark a slash on a 100 mm line the muscle soreness of their lower extremities, with descriptors of "no soreness'' indicated at 0 and ''unbearably painful" at 100.
Participants will rate overall lower-extremity soreness at rest, while performing a stand-to-sit movement, and while running at a moderate pace.
|
Two days before a 40-minute downhill run, the day of a 40-minute downhill run, 24 hours after a 40-minute downhill run and the two days after a 40-minute downhill run
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Pressure Threshold Change
Time Frame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
|
An algometer will be applied to the participant's quadriceps muscle.
An algometer is a handheld device with an integral load cell that transduces the pressure applied to the participant.
The investigator will apply force slowly and smoothly while the participant concentrates on when the force applied by the investigator transitions from a feeling of pressure to a feeling of pain.
The force level applied when the participant begins to feel pain will be considered the pain pressure threshold.
The location of the measurement will be 10 cm above the superior crest of the patella.
The average of two measurements will be taken.
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Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
|
|
Vertical Jump Test Change
Time Frame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
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Participants will jump as high as possible using the squat jump technique.
Participants will perform three trials.
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Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
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1.5-mile Run Change
Time Frame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
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Participants will complete a maximal effort 1.5-mile run on a motorized treadmill.
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Two days before a 40-minute downhill run and two days after a 40-minute downhill run
|
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Lung Function Change
Time Frame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
|
Participants' lung function will be tested before the 1.5-mile run and at 1, 5, 10, 15, and 20 minutes post-exercise.
Lung function will be assessed with a spirometer by having participants perform a maximal forced expiration.
Breathing difficulty will also be measured before and after the run with the Modified Borg Dyspnea Scale.
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Two days before a 40-minute downhill run and two days after a 40-minute downhill run
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (ACTUAL)
June 1, 2017
Study Completion (ACTUAL)
June 1, 2017
Study Registration Dates
First Submitted
January 14, 2017
First Submitted That Met QC Criteria
January 18, 2017
First Posted (ESTIMATE)
January 23, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 20, 2017
Last Update Submitted That Met QC Criteria
December 18, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 934537-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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