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

Primary Purpose

Muscle Soreness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ginger Root
Placebo
Sponsored by
Old Dominion University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Soreness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Human Performance Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginger Root Capsule

Placebo Capsule

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Vertical Jump Test Change
Participants will jump as high as possible using the squat jump technique. Participants will perform three trials.
1.5-mile Run Change
Participants will complete a maximal effort 1.5-mile run on a motorized treadmill.
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.

Full Information

First Posted
January 14, 2017
Last Updated
December 18, 2017
Sponsor
Old Dominion University
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1. Study Identification

Unique Protocol Identification Number
NCT03028454
Brief Title
Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
Official Title
Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Old Dominion University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginger Root Capsule
Arm Type
Experimental
Arm Title
Placebo Capsule
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginger Root
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Capsules containing rice flour powder.
Primary Outcome Measure Information:
Title
Muscle Soreness Change
Description
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.
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
Secondary Outcome Measure Information:
Title
Pain Pressure Threshold Change
Description
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.
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
Title
Vertical Jump Test Change
Description
Participants will jump as high as possible using the squat jump technique. Participants will perform three trials.
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
Title
1.5-mile Run Change
Description
Participants will complete a maximal effort 1.5-mile run on a motorized treadmill.
Time Frame
Two days before a 40-minute downhill run and two days after a 40-minute downhill run
Title
Lung Function Change
Description
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.
Time Frame
Two days before a 40-minute downhill run and two days after a 40-minute downhill run

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Human Performance Laboratory
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529
Country
United States

12. IPD Sharing Statement

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

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