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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
36
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.
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.
Purdue University, Department of Nutrition Science
West Lafayette, Indiana, United States
Change in serum 25-hydroxy-vitamin D2 concentration
25(OH) Vitamin D2/D3 by LC/MS
Time frame: 12 weeks
Change in immunity/inflammation markers
Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)
Time frame: 12 weeks
Change in immunity/inflammation markers
High Sensitivity C Reactive Protein (hs-CRP)
Time frame: 12 weeks
Change in immunity/inflammation markers
Cytokine 13 Panel (pg/mL)
Time frame: 12 weeks
Change in bone remodeling
Osteocalcin
Time frame: 12 weeks
Change in serum calcium concentrations
Parathyroid hormone (PTH)
Time frame: 12 weeks
Change in perceived depression from baseline to mid to post-intervention
Beck's Depression Inventory questionnaire
Time frame: 12 weeks
Change in perceived anxiety from baseline to mid to post-intervention
Patient Health Questionnaire-9
Time frame: 12 weeks
Change in cognitive function from baseline to mid to post-intervention
Repeatable Battery for the Assessment of Neuropsychological Status
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Time frame: 12 weeks
Change in perceived daily mood from baseline to mid to post-intervention
Profile of Mood States
Time frame: 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
Time frame: 12 weeks
Risk factors for cardiovascular disease
Complete metabolic panel
Time frame: 12 weeks
Risk factors for cardiovascular disease
Blood pressure
Time frame: 12 weeks
Risk factors for cardiovascular disease
Lipoprotein Particle Plus (LPP+) Panel
Time frame: 12 weeks
Risk factors for cardiovascular disease
Complete blood count (CBC)
Time frame: 12 weeks
Risk factors for type 2 diabetes
Complete metabolic panel
Time frame: 12 weeks
Body weight
Measures of weight (kg)
Time frame: 12 weeks