Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults

Study Overview
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Brief Summary
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We propose to assess the effects of including vitamin D-enriched mushrooms as part of participants' usual eating pattern primarily on 25(OH) vitamin D2 status and secondarily on immune function and inflammatory status.

Detailed Description
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We hypothesize that consuming vitamin D-enriched mushrooms daily for 12 weeks will prevent decreases in serum 25-hydroxy-vitamin D2 concentrations. Secondarily, we hypothesize consuming vitamin D-enriched mushrooms daily for 12 weeks will improve clinical indicators of inflammatory status and alter/enhance immune status and immune cell function. This short-term randomized, controlled trial will provide important data to inform the plausibility, focus, and design of longer-term intervention trials, consistent with The Mushroom Council's research agenda regarding health-promoting effects of vitamin D-enriched mushrooms.

Official Title
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Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function in Adults

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Other: Vitamin D-enriched mushrooms
* Other: Study Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI: 25.0-34.9 kg/m^2 Total cholesterol <240 mg/dL low density lipoprotein cholesterol < 160 mg/dL triglycerides <300 mg/dL fasting glucose < 110 mg/dL systolic/diastolic blood pressure < 140/90 mmHg body weight stable for 3 months prior (+- 3 kg) stable physical activity regiment 3 months prior medication use stable for 6 months prior non-smoking non-diabetic not acutely ill females not pregnant or lactating willing to refrain from taking vitamin D supplements or any supplements containing vitamin D No history of bariatric surgery Not extremely or severely depressed (Beck's Depression Inventory Score <= 30) Agree not to donate blood for at least one month prior to, during, and for one month after the study Agree not to travel to sunny locations during the study period Agree to forgo any tanning bed or other tanning procedures during the study Willing and able to consume mushrooms and travel to testing facilities Exclusion Criteria: Age <30 or >70 BMI <25 or >35kg/m2 Total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160 mg/dL, triglycerides >300mg/dL, fasting glucose >110 mg/dL Systolic/diastolic blood pressure >140/90 mm Hg Body weight changes in previous 3 months (±3 kg) Changes in physical activity regimen in the previous 3 months Medication changes in the previous 6 months Extremely or severely depressed (Beck's Depression Inventory Score >30) Unwilling to refrain from taking vitamin D supplements or any supplements containing vitamin D Regiment of megadosing vitamin D Unwilling to not to travel to sunny locations during the study period Unwilling to forgo any tanning bed or other tanning procedures during the study History of bariatric surgery Consuming a restricted diet (such as keto, gluten free, high protein, low carb, etc.) Smoking Diabetic Acute illness Females pregnant or lactating Unwilling to not to donate blood for at least one month prior to, during, and for one month after the study Allergic to mushrooms or bread

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For this investigator-blinded, randomized, parallel design study, 50 participants (40 to finish; n=20/group) will complete a 12-week study period in which participants consume 84 g of vitamin-D enriched mushrooms containing 800 IU/serving or study powder (control) in the context of their usual diet. To assess the effects of including vitamin D-enriched mushrooms as part of participants' usual eating pattern on serum vitamin D status and indices of immune function and inflammatory status, we will measure circulating concentrations of 25-hydroxy-vitamin D2, pro- and anti-inflammatory cytokines, and immunoglobulins, among other immunity/inflammation outcomes. Health questionnaires related to perceived anxiety/depression and wellbeing are included to complement the currently funded longitudinal feeding study which includes these exploratory outcomes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mushrooms<br>Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks. | Other: Vitamin D-enriched mushrooms<br>* Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily (for a total of 168g per day) for 12 weeks.<br>|
| Placebo Comparator: No Mushrooms<br>This is a behavioral control where no change in Vitamin D status is expected to occur. Participants will consume their usual, unrestricted, self-selected diet plus 1 tsp of dried study powder twice daily for 12 weeks. | Other: Study Powder<br>* Participants will consume their usual, unrestricted, self-selected diet plus 1 tsp of dried study powder twice daily (2 tsp total per day) for 12 weeks. Study powder is a commercially available carbohydrate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum 25-hydroxy-vitamin D2 concentration | 25(OH) Vitamin D2/D3 by LC/MS | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immunity/inflammation markers | Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL) | 12 weeks | 
| Change in immunity/inflammation markers | High Sensitivity C Reactive Protein (hs-CRP) | 12 weeks | 
| Change in immunity/inflammation markers | Cytokine 13 Panel (pg/mL) | 12 weeks | 
| Change in bone remodeling | Osteocalcin | 12 weeks | 
| Change in serum calcium concentrations | Parathyroid hormone (PTH) | 12 weeks | 
| Change in perceived depression from baseline to mid to post-intervention | Beck's Depression Inventory questionnaire | 12 weeks | 
| Change in perceived anxiety from baseline to mid to post-intervention | Patient Health Questionnaire-9 | 12 weeks | 
| Change in cognitive function from baseline to mid to post-intervention | Repeatable Battery for the Assessment of Neuropsychological Status | 12 weeks | 
| Change in perceived daily mood from baseline to mid to post-intervention | Profile of Mood States | 12 weeks | 
| Change in perceived quality of life from baseline to mid to post-intervention | Medical Outcomes Study 36-Item Short Form Health Survey Version 2 | 12 weeks | 
| Risk factors for cardiovascular disease | Complete metabolic panel | 12 weeks | 
| Risk factors for cardiovascular disease | Blood pressure | 12 weeks | 
| Risk factors for cardiovascular disease | Lipoprotein Particle Plus (LPP+) Panel | 12 weeks | 
| Risk factors for cardiovascular disease | Complete blood count (CBC) | 12 weeks | 
| Risk factors for type 2 diabetes | Complete metabolic panel | 12 weeks | 
| Body weight | Measures of weight (kg) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mushroom, Immune function, Vitamin D2, randomized controlled trial