Vitamin D2, Muscle Damage, NASCAR Pitcrew
Primary Purpose
Muscle Function, Muscle Soreness, Vitamin D Status
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D2 mushroom powder
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Muscle Function focused on measuring Strength, Anaerobic power, Muscle soreness, Immune function
Eligibility Criteria
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.
Sites / Locations
- ASU Human Performance Laboratory, North Carolina Research Campus
- ASU-NCRC Human Performance Laboratory
- ASU-NCRC Human Performance Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D2 mushroom powder
Placebo
Arm Description
4000 IU/day vitamin D2 mushroom powder
Mushroom powder without vitamin D2 (not exposed to UV radiation)
Outcomes
Primary Outcome Measures
Muscle damage
myoglobin (ug/L) and creatine kinase (IU/L) after eccentric resistance exercise
Muscle Function
Bench press of body weight, reps to fatigue Vertical jump (watts( 300 yard shuttle run (seconds) 30-sec Wingate anaerobic power test (watts/kg)
Secondary Outcome Measures
Serum vitamin D concentration
25(OH)D2 and 25(OH)D3
Immune Function
White blood cell differential Myeloperoxidase Immune cell cytotoxicity
Full Information
NCT ID
NCT01825616
First Posted
April 3, 2013
Last Updated
April 8, 2013
Sponsor
Appalachian State University
Collaborators
Dole Food Company
1. Study Identification
Unique Protocol Identification Number
NCT01825616
Brief Title
Vitamin D2, Muscle Damage, NASCAR Pitcrew
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Appalachian State University
Collaborators
Dole Food Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Six weeks of supplementation with vitamin D (4000 IU/day) using Dole's Vitamin D Portobello Mushroom Powder will increase winter serum vitamin D levels, and improve muscle function and strength, and innate immunity (granulocyte/monocyte phagocytosis and oxidative burst activity), and attenuate exercise-induced muscle damage and DOMS.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Function, Muscle Soreness, Vitamin D Status
Keywords
Strength, Anaerobic power, Muscle soreness, Immune function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D2 mushroom powder
Arm Type
Experimental
Arm Description
4000 IU/day vitamin D2 mushroom powder
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Mushroom powder without vitamin D2 (not exposed to UV radiation)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D2 mushroom powder
Other Intervention Name(s)
UV radiated Portobello mushroom powder
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Mushroom powder without vitamin D2
Primary Outcome Measure Information:
Title
Muscle damage
Description
myoglobin (ug/L) and creatine kinase (IU/L) after eccentric resistance exercise
Time Frame
6 weeks
Title
Muscle Function
Description
Bench press of body weight, reps to fatigue Vertical jump (watts( 300 yard shuttle run (seconds) 30-sec Wingate anaerobic power test (watts/kg)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Serum vitamin D concentration
Description
25(OH)D2 and 25(OH)D3
Time Frame
6 weeks
Title
Immune Function
Description
White blood cell differential Myeloperoxidase Immune cell cytotoxicity
Time Frame
6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Nieman, DrPH
Organizational Affiliation
Appalachian State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASU Human Performance Laboratory, North Carolina Research Campus
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
Facility Name
ASU-NCRC Human Performance Laboratory
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
Facility Name
ASU-NCRC Human Performance Lab
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ncrc.appstate.edu
Description
Lab web site
Learn more about this trial
Vitamin D2, Muscle Damage, NASCAR Pitcrew
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