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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01443897
First received: September 28, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in serum Vitamin D2 [ Time Frame: 0, 3 and 6 weeks ] [ Designated as safety issue: No ]
    Serum vitamin D 2 will be measured in serum.


Secondary Outcome Measures:
  • Change in serum markers of inflammation [ Time Frame: 0, 3, and 6 weeks ] [ Designated as safety issue: No ]
    Measure serum cytokines, chemokines, and neopterin.


Enrollment: 48
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1
Untreated mushrooms plus placebo capsule.
Dietary Supplement: placebo capsule
0 IU vitamin D2
Other: mushrooms
untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA
Experimental: Group 2
UVB-treated mushrooms (400 IU vitamin D2 per serving) plus placebo capsule.
Dietary Supplement: placebo capsule
0 IU vitamin D2
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
Experimental: Group 3
UVB-treated mushrooms (1,000 IU vitamin D2 per serving) plus placebo capsule.
Dietary Supplement: placebo capsule
0 IU vitamin D2
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
Experimental: Group 4
Untreated mushrooms plus 1,000 IU Vitamin D2 in capsule
Dietary Supplement: 1,000 IU vitamin D2
capsule containing 1,000 IU vitamin D2
Other: mushrooms
untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA

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.

  Eligibility

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443897

Locations
United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Charles B Stephensen, PhD USDA, ARS, Western Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01443897     History of Changes
Other Study ID Numbers: 201017924-1
Study First Received: September 28, 2011
Last Updated: September 28, 2011
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
Vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014