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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: placebo capsule; Other: mushrooms; Other: UVB-treated mushrooms, 400 IU vitamin D2; Other: UVB-treated mushrooms, 1,000 IU vitamin D2; Dietary supplement: 1,000 IU vitamin D2

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: mushrooms; untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA; Dietary supplement: 1,000 IU vitamin D2; capsule containing 1,000 IU vitamin D2

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Investigators: Principal Investigator: Charles B Stephensen, PhD, USDA, ARS, Western Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (ESTIMATE): September 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Vitamin D
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 201017924-1