NCT03028454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

January 14, 2017

Last Update Submit

December 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Pain Pressure Threshold Change

    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

    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

    Two days before a 40-minute downhill run and two days after a 40-minute downhill run

  • Lung Function Change

    Two days before a 40-minute downhill run and two days after a 40-minute downhill run

Study Arms (2)

Ginger Root Capsule

EXPERIMENTAL
Dietary Supplement: Ginger Root

Placebo Capsule

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

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.

Ginger Root Capsule
PlaceboDIETARY_SUPPLEMENT

Capsules containing rice flour powder.

Placebo Capsule

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be currently running ≥10 miles per week
  • Have completed at least one run \>40 minutes over the past month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Exercise Science

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 23, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations