Vitamin D2, Muscle Damage, NASCAR Pitcrew

NCT ID: NCT01825616

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-01-31

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.

Conditions

Muscle Function; Muscle Soreness; Vitamin D Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D2 mushroom powder

4000 IU/day vitamin D2 mushroom powder

Group Type: EXPERIMENTAL

Vitamin D2 mushroom powder

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo

Mushroom powder without vitamin D2 (not exposed to UV radiation)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Mushroom powder without vitamin D2

Interventions

Vitamin D2 mushroom powder

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: DIETARY_SUPPLEMENT

Placebo

Mushroom powder without vitamin D2

Intervention Type: OTHER

Other Intervention Names

UV radiated Portobello mushroom powder

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dole Food Company

INDUSTRY

Sponsor Role: collaborator

Appalachian State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C Nieman, DrPH

Role: PRINCIPAL_INVESTIGATOR

Appalachian State University

Locations

ASU Human Performance Laboratory, North Carolina Research Campus

Kannapolis, North Carolina, United States

ASU-NCRC Human Performance Laboratory

Kannapolis, North Carolina, United States

ASU-NCRC Human Performance Lab

Kannapolis, North Carolina, United States

Countries

United States

Related Links

http://www.ncrc.appstate.edu

Lab web site

Other Identifiers

12_0355

Identifier Type: -

Identifier Source: org_study_id