Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running

• ClinicalTrials.gov Identifier: NCT03028454
• Recruitment Status: Completed
• First Posted: January 23, 2017
• Last Update Posted: December 20, 2017
• Sponsor: Old Dominion University
• Information provided by (Responsible Party): Patrick Wilson, PhD, Old Dominion University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Muscle Soreness	Dietary Supplement: Ginger Root; Dietary Supplement: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
• Study Start Date: January 2017
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ginger Root Capsule	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 Comparator: Placebo Capsule	Dietary Supplement: Placebo; Capsules containing rice flour powder.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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 ]
   Participants will jump as high as possible using the squat jump technique. Participants will perform three trials.
3. 1.5-mile Run Change [ Time Frame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run ]
   Participants will complete a maximal effort 1.5-mile run on a motorized treadmill.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Virginia

Human Performance Laboratory

Norfolk, Virginia, United States, 23529

Sponsors and Collaborators

Old Dominion University

More Information

• Responsible Party: Patrick Wilson, PhD, Assistant Professor of Exercise Science, Old Dominion University
• ClinicalTrials.gov Identifier: NCT03028454
• Other Study ID Numbers: 934537-3
• First Posted: January 23, 2017
• Last Update Posted: December 20, 2017
• Last Verified: December 2017

Additional relevant MeSH terms:

Myalgia; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations