Muscle SorenessNCT03028454
Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
A study testing Ginger Root in people with Muscle Soreness, run by Old Dominion University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Ginger Root
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be currently running ≥10 miles per week
- Have completed at least one run >40 minutes over the past month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Performance Laboratory
Norfolk, Virginia, 23529
About this study
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.
- Conditions
- Muscle Soreness
- Being tested
- Ginger Root, Placebo
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger RootDietary supplement
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.
PlaceboDietary supplement
Capsules containing rice flour powder.
| Study group | Role | What they receive |
|---|---|---|
| Ginger Root Capsule | Experimental | Not described Receives: Dietary Supplement: Ginger Root |
| Placebo Capsule | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Soreness Change
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.
Measured: 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
Secondary outcomes (4)
Pain Pressure Threshold Change
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.
Measured: 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
Participants will jump as high as possible using the squat jump technique. Participants will perform three trials.
Measured: 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
1.5-mile Run Change
Participants will complete a maximal effort 1.5-mile run on a motorized treadmill.
Measured: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
Lung Function Change
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.
Measured: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Wilson, PhD, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028454
- Sponsor's protocol ID
- 934537-3
- Status last verified
- Dec 2017
- First submitted
- 14 Jan 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
- ClinicalTrials.gov ID
- NCT03028454
- Acronym / sponsor ID
- 934537-3
- Conditions
- Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger Root Capsule | Experimental | Dietary Supplement: Ginger Root |
| Placebo Capsule | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be currently running ≥10 miles per week
- Have completed at least one run >40 minutes over the past month
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger RootCapsules 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. | Dietary supplement | Ginger Root Capsule |
| PlaceboCapsules containing rice flour powder. | Dietary supplement | Placebo Capsule |
Primary outcome
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.
4 secondary outcomes
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
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
1.5-mile Run Change
Time frame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
Lung Function Change
Time frame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger Root in people with Muscle Soreness, run by Old Dominion University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.