Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
1 other identifier
interventional
48
1 country
1
Brief Summary
This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase their vitamin D2 content are actually a good source of vitamin D when consumed daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which will be a standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in vitamin D status affects the immune system by decreasing it's level of activation, which may be abnormally elevated in vitamin D deficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
1 active site
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
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedSeptember 30, 2011
September 1, 2011
6 months
September 28, 2011
September 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in serum Vitamin D2
Serum vitamin D 2 will be measured in serum.
0, 3 and 6 weeks
Secondary Outcomes (1)
Change in serum markers of inflammation
0, 3, and 6 weeks
Study Arms (4)
Group 1
PLACEBO COMPARATORUntreated mushrooms plus placebo capsule.
Group 2
EXPERIMENTALUVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule.
Group 3
EXPERIMENTALUVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule.
Group 4
EXPERIMENTALUntreated mushrooms plus 1,000 IU Vitamin D2 in capsule
Interventions
untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA
UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA
UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA
Eligibility Criteria
You may qualify if:
- willing to consume a lunch meal 7 days per week for 6 weeks containing mushrooms
- willing to stop eating other sources of mushrooms
- willing to discontinue taking vitamin D and other dietary supplements
- estimated low vitamin D status based on dietary questionnaire, skin reflectance, and sun behavior
You may not qualify if:
- women who are pregnant or breastfeeding
- volunteers with anemia
- volunteers with evidence of underlying disease affecting vitamin D metabolism
- volunteers taking medications altering vitamin D metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles B Stephensen, PhD
USDA, ARS, Western Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
September 30, 2011
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
June 1, 2011
Last Updated
September 30, 2011
Record last verified: 2011-09