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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03028454
Other study ID # 934537-3
Secondary ID
Status Completed
Phase N/A
First received January 14, 2017
Last updated December 18, 2017
Start date January 2017
Est. completion date June 2017

Study information

Verified date December 2017
Source Old Dominion University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ginger Root
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.
Placebo
Capsules containing rice flour powder.

Locations

Country Name City State
United States Human Performance Laboratory Norfolk Virginia

Sponsors (1)

Lead Sponsor Collaborator
Old Dominion University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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. 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
Secondary Vertical Jump Test Change Participants will jump as high as possible using the squat jump technique. Participants will perform three trials. 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
Secondary 1.5-mile Run Change Participants will complete a maximal effort 1.5-mile run on a motorized treadmill. Two days before a 40-minute downhill run and two days after a 40-minute downhill run
Secondary 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. Two days before a 40-minute downhill run and two days after a 40-minute downhill run
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