Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1,000 IU vitamin D2
placebo capsule
mushrooms
UVB-treated mushrooms, 400 IU vitamin D2
UVB-treated mushrooms, 1,000 IU vitamin D2
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- USDA, ARS, Western Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Untreated mushrooms plus placebo capsule.
UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule.
UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule.
Untreated mushrooms plus 1,000 IU Vitamin D2 in capsule
Outcomes
Primary Outcome Measures
Change in serum Vitamin D2
Serum vitamin D 2 will be measured in serum.
Secondary Outcome Measures
Change in serum markers of inflammation
Measure serum cytokines, chemokines, and neopterin.
Full Information
NCT ID
NCT01443897
First Posted
September 28, 2011
Last Updated
September 28, 2011
Sponsor
USDA, Western Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01443897
Brief Title
Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
Official Title
Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Volunteers will be asked to consume a standard meal (lunch) containing one serving of mushrooms daily for six weeks (7 days per week). With the meal, they will also need to take one capsule. The capsule will be either a placebo or will contain vitamin D. The purpose of the vitamin D in the capsule is to determine if the vitamin D from the mushrooms is absorbed as well as vitamin D from a capsule. The total dose of vitamin D that volunteers will receive each day from mushrooms and capsule together will always be the same and will be one of three doses: (1) little or no vitamin D (placebo); (2) 400 IU, which is near the current recommended intake and (3) 1,000 IU, which is up to five-fold higher than the current recommended intake, depending on your age. Both levels of vitamin D are safe. In addition to consuming the meals and taking the capsules, up to 20 mL (4 teaspoons) of blood will be drawn at three times during the study just before the mushroom-containing lunch is provided: (1) at the beginning of the study before the first meal; (3) after three weeks; (3) at the end of the study. The purpose of the blood draw is to measure vitamin D in your blood and to measure the level of activation of your immune system by measuring markers of immune activation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Untreated mushrooms plus placebo capsule.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Untreated mushrooms plus 1,000 IU Vitamin D2 in capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
1,000 IU vitamin D2
Intervention Description
capsule containing 1,000 IU vitamin D2
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo capsule
Intervention Description
0 IU vitamin D2
Intervention Type
Other
Intervention Name(s)
mushrooms
Intervention Description
untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA
Intervention Type
Other
Intervention Name(s)
UVB-treated mushrooms, 400 IU vitamin D2
Intervention Description
UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA
Intervention Type
Other
Intervention Name(s)
UVB-treated mushrooms, 1,000 IU vitamin D2
Intervention Description
UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA
Primary Outcome Measure Information:
Title
Change in serum Vitamin D2
Description
Serum vitamin D 2 will be measured in serum.
Time Frame
0, 3 and 6 weeks
Secondary Outcome Measure Information:
Title
Change in serum markers of inflammation
Description
Measure serum cytokines, chemokines, and neopterin.
Time Frame
0, 3, and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles B Stephensen, PhD
Organizational Affiliation
USDA, ARS, Western Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA, ARS, Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
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