NCT01825616

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

3 months

First QC Date

April 3, 2013

Last Update Submit

April 8, 2013

Conditions

Muscle FunctionMuscle SorenessVitamin D Status

Keywords

StrengthAnaerobic powerMuscle sorenessImmune function

Outcome Measures

Primary Outcomes (2)

  • Muscle damage

    myoglobin (ug/L) and creatine kinase (IU/L) after eccentric resistance exercise

    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)

    6 weeks

Secondary Outcomes (2)

  • Serum vitamin D concentration

    6 weeks

  • Immune Function

    6 weeks

Study Arms (2)

Vitamin D2 mushroom powder

EXPERIMENTAL

4000 IU/day vitamin D2 mushroom powder

Dietary Supplement: Vitamin D2 mushroom powder

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vitamin D2 mushroom powderDIETARY_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.

Also known as: UV radiated Portobello mushroom powder
Vitamin D2 mushroom powder
PlaceboOTHER

Mushroom powder without vitamin D2

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Not allergic to mushrooms.
  • Do not have a heart problem or have been told by your doctor not to engage in vigorous exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ASU Human Performance Laboratory, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

ASU-NCRC Human Performance Laboratory

Kannapolis, North Carolina, 28081, United States

Location

ASU-NCRC Human Performance Lab

Kannapolis, North Carolina, 28081, United States

Location

Related Links

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

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

Study Officials

  • David C Nieman, DrPH

    Appalachian State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 5, 2013

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

US(3)