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

NCT ID: NCT01443897

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

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.

Conditions

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Vitamin D Deficiency

Keywords

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Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Untreated mushrooms plus placebo capsule.

Group Type PLACEBO_COMPARATOR

placebo capsule

Intervention Type DIETARY_SUPPLEMENT

0 IU vitamin D2

mushrooms

Intervention Type OTHER

untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA

Group 2

UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule.

Group Type EXPERIMENTAL

placebo capsule

Intervention Type DIETARY_SUPPLEMENT

0 IU vitamin D2

UVB-treated mushrooms, 400 IU vitamin D2

Intervention Type OTHER

UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA

Group 3

UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule.

Group Type EXPERIMENTAL

placebo capsule

Intervention Type DIETARY_SUPPLEMENT

0 IU vitamin D2

UVB-treated mushrooms, 1,000 IU vitamin D2

Intervention Type OTHER

UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA

Group 4

Untreated mushrooms plus 1,000 IU Vitamin D2 in capsule

Group Type EXPERIMENTAL

1,000 IU vitamin D2

Intervention Type DIETARY_SUPPLEMENT

capsule containing 1,000 IU vitamin D2

mushrooms

Intervention Type OTHER

untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA

Interventions

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1,000 IU vitamin D2

capsule containing 1,000 IU vitamin D2

Intervention Type DIETARY_SUPPLEMENT

placebo capsule

0 IU vitamin D2

Intervention Type DIETARY_SUPPLEMENT

mushrooms

untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA

Intervention Type OTHER

UVB-treated mushrooms, 400 IU vitamin D2

UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA

Intervention Type OTHER

UVB-treated mushrooms, 1,000 IU vitamin D2

UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles B Stephensen, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA, ARS, Western Human Nutrition Research Center

Locations

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USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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201017924-1

Identifier Type: -

Identifier Source: org_study_id