Muscle FunctionNCT01825616
Vitamin D2, Muscle Damage, NASCAR Pitcrew
A study testing Vitamin D2 mushroom powder in people with Muscle Function and Muscle Soreness, run by Appalachian State University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Function, Muscle Soreness, Vitamin D Status
- What is being tested?
- Vitamin D2 mushroom powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Not allergic to mushrooms.
- Do not have a heart problem or have been told by your doctor not to engage in vigorous exercise.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, 28081
ASU-NCRC Human Performance Laboratory
Kannapolis, North Carolina, 28081
ASU-NCRC Human Performance Lab
Kannapolis, North Carolina, 28081
About this study
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
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.
Read the 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
- Being tested
- Vitamin D2 mushroom powder, Placebo
- Keywords
- Strength, Anaerobic power, Muscle soreness, Immune function
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2 mushroom powderDietary supplement
Also called UV radiated Portobello 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.
PlaceboOther
Mushroom powder without vitamin D2
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D2 mushroom powder | Experimental | 4000 IU/day vitamin D2 mushroom powder Receives: Dietary Supplement: Vitamin D2 mushroom powder |
| Placebo | Placebo comparator | Mushroom powder without vitamin D2 (not exposed to UV radiation) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle damage
myoglobin (ug/L) and creatine kinase (IU/L) after eccentric resistance exercise
Measured: 6 weeks
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)
Measured: 6 weeks
Secondary outcomes (2)
Serum vitamin D concentration
25(OH)D2 and 25(OH)D3
Measured: 6 weeks
Immune Function
White blood cell differential Myeloperoxidase Immune cell cytotoxicity
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Dole Food Company
- Responsible party
- Sponsor
- Investigators
- David C Nieman, DrPH, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825616
- Sponsor's protocol ID
- 12_0355
- Status last verified
- Apr 2013
- First submitted
- 3 Apr 2013
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01825616
- Acronym / sponsor ID
- 12_0355
- Conditions
- Muscle Function, Muscle Soreness, Vitamin D Status
- Keywords
- Strength, Anaerobic power, Muscle soreness, Immune function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Dole Food Company
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 mushroom powder | Experimental | Dietary Supplement: Vitamin D2 mushroom powder4000 IU/day vitamin D2 mushroom powder |
| Placebo | Placebo comparator | Other: PlaceboMushroom powder without vitamin D2 (not exposed to UV radiation) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Not allergic to mushrooms.
- Do not have a heart problem or have been told by your doctor not to engage in vigorous exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2 mushroom powderAlso: UV radiated Portobello mushroom powderSubjects 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. | Dietary supplement | Vitamin D2 mushroom powder |
| PlaceboMushroom powder without vitamin D2 | Other | Placebo |
Primary outcome
Muscle damage
Time frame: 6 weeks
myoglobin (ug/L) and creatine kinase (IU/L) after eccentric resistance exercise
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)
2 secondary outcomes
Serum vitamin D concentration
Time frame: 6 weeks
Immune Function
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Lab web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Nieman, DrPH principal investigator
Appalachian State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D2 mushroom powder in people with Muscle Function and Muscle Soreness, run by Appalachian State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle damage (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2013.