Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: 1,000 IU vitamin D2
* Dietary Supplement: placebo capsule
* Other: mushrooms
* Other: UVB-treated mushrooms, 400 IU vitamin D2
* Other: UVB-treated mushrooms, 1,000 IU vitamin D2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Untreated mushrooms plus placebo capsule. | Dietary Supplement: placebo capsule<br>* 0 IU vitamin D2<br>Other: mushrooms<br>* untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA<br>|
| Experimental: Group 2<br>UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule. | Dietary Supplement: placebo capsule<br>* 0 IU vitamin D2<br>Other: UVB-treated mushrooms, 400 IU vitamin D2<br>* UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA<br>|
| Experimental: Group 3<br>UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule. | Dietary Supplement: placebo capsule<br>* 0 IU vitamin D2<br>Other: UVB-treated mushrooms, 1,000 IU vitamin D2<br>* UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA<br>|
| Experimental: Group 4<br>Untreated mushrooms plus 1,000 IU Vitamin D2 in capsule | Dietary Supplement: 1,000 IU vitamin D2<br>* capsule containing 1,000 IU vitamin D2<br>Other: mushrooms<br>* untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum Vitamin D2 | Serum vitamin D 2 will be measured in serum. | 0, 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum markers of inflammation | Measure serum cytokines, chemokines, and neopterin. | 0, 3, and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D