- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01825616
Vitamin D2, Muscle Damage, NASCAR Pitcrew
Influence of 6-weeks Supplementation With Vitamin D Portobello Mushroom Powder on Muscle Function and Performance, Innate Immune Function, and Exercise-induced Muscle Damage and DOMS in NASCAR Pit Crew Members
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Vitamin D2 is found naturally in sun-exposed mushrooms, and vitamin D3 is synthesized in the skin when exposed to sunlight and is present in oil-rich fish such as salmon, mackerel, and herring. Mushrooms contain very little or any vitamin D2 but are abundant in ergosterol, which can be converted into vitamin D2 by ultraviolet (UV) illumination (Eur J Clin Nutr. 2011;65:965-71).
In recent decades, there has been increased awareness of the impact of vitamin D on muscle function (Scand J Med Sci Sports. 2010;20:182-90). In the early 20th century, athletes and coaches felt that ultraviolet rays had a positive impact on athletic performance, and evidence is accumulating to support this view. Both cross-sectional and longitudinal studies support a functional role for vitamin D in muscle, and the discovery of the vitamin D receptor in muscle tissue provides a mechanistic pathway for understanding the role of vitamin D within muscle. Studies in athletes have found that vitamin D status is variable and is dependent on outdoor training time (during peak sunlight), skin color, and geographic location (Pediatr Clin North Am. 2010;57:849-61).
25(OH)D is the best indicator and major form of vitamin D in the blood, with a circulating half-life of 2-3 weeks. Vitamin D deficiency is defined as a plasma vitamin D [25(OH)D] level of less than 20 ng/ml, with vitamin D insufficiency defined as 21-29 ng/ml. Estimates are that 20-100% of children, young and middle-aged adults, and community-dwelling elderly men and women are vitamin D deficient (J Clin Endocrinol Metab. 2011;96:1911-30).
Purpose: To determine if 6 weeks supplementation with Dole Vitamin D Portobello Mushroom Powder (4,000 IU/day) can, 1) increase winter serum vitamin D levels, and measure whether vitamin D supplementation 2) has a chronic influence on muscle function and strength, and innate immune function, and 3) can attenuate exercise-induced muscle damage and delayed onset of muscle soreness (DOMS) in athletes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Kannapolis, North Carolina, United States, 28081
- ASU Human Performance Laboratory, North Carolina Research Campus
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Kannapolis, North Carolina, United States, 28081
- ASU-NCRC Human Performance Lab
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Kannapolis, North Carolina, United States, 28081
- ASU-NCRC Human Performance Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- NASCAR pit crew members
- Willing to avoid food and supplement sources (during the 6-week supplementation period) that are high in vitamin D (specifically canned fish, cod liver oil, salmon, and supplements with high-dose vitamin D).
- Agree to train normally.
- Avoid the use of large dose vitamin/mineral supplements (above 100% recommended dietary allowances), and medications known to affect immune function.
- Avoid the use of tanning beds.
- Willing to adhere to all aspects of the study design.
Exclusion Criteria:
- Not allergic to mushrooms.
- Do not have a heart problem or have been told by your doctor not to engage in vigorous exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vitamin D2 mushroom powder
4000 IU/day vitamin D2 mushroom powder
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Subjects will be given Portobello mushroom powder with or without vitamin D mixed in soymilk powder in six plastic containers (one for each week of the study).
Subjects will ingest one level teaspoon of the product each day (with or without 4,000 IU vitamin D2) and consume during breakfast in one of the following ways: mixed in water, juice, yogurt, or milk.
Other Names:
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Placebo Comparator: Placebo
Mushroom powder without vitamin D2 (not exposed to UV radiation)
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Mushroom powder without vitamin D2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle damage
Time Frame: 6 weeks
|
myoglobin (ug/L) and creatine kinase (IU/L) after eccentric resistance exercise
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6 weeks
|
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Muscle Function
Time Frame: 6 weeks
|
Bench press of body weight, reps to fatigue Vertical jump (watts( 300 yard shuttle run (seconds) 30-sec Wingate anaerobic power test (watts/kg)
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum vitamin D concentration
Time Frame: 6 weeks
|
25(OH)D2 and 25(OH)D3
|
6 weeks
|
|
Immune Function
Time Frame: 6 weeks
|
White blood cell differential Myeloperoxidase Immune cell cytotoxicity
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6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Musculoskeletal Pain
- Myalgia
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Ergocalciferols
Other Study ID Numbers
- 12_0355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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