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Completed

NCT Number: NCT01443897

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

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.

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Key information

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1,000 IU vitamin D2

Dietary Supplement

capsule containing 1,000 IU vitamin D2

placebo capsule

Dietary Supplement

0 IU vitamin D2

mushrooms

Other

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

UVB-treated mushrooms, 400 IU vitamin D2

Other

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

UVB-treated mushrooms, 1,000 IU vitamin D2

Other

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

Primary outcomes

  1. Change in serum Vitamin D2

    Time frame: 0, 3 and 6 weeks

    Serum vitamin D 2 will be measured in serum.

Secondary outcomes

  1. Change in serum markers of inflammation

    Time frame: 0, 3, and 6 weeks

    Measure serum cytokines, chemokines, and neopterin.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 30, 2011
Registry last updated
Sep 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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