Purdue University, Department of Nutrition Science
West Lafayette, Indiana, 47907, United States
NCT Number: NCT05559112
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.
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Notify Me30 year–69 year
All sexes
Interventional
Not applicable
West Lafayette, Indiana, 47907, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 weeks
25(OH) Vitamin D2/D3 by LC/MS
Time frame: 12 weeks
Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)
Time frame: 12 weeks
High Sensitivity C Reactive Protein (hs-CRP)
Time frame: 12 weeks
Cytokine 13 Panel (pg/mL)
Time frame: 12 weeks
Osteocalcin
Time frame: 12 weeks
Parathyroid hormone (PTH)
Time frame: 12 weeks
Beck's Depression Inventory questionnaire
Time frame: 12 weeks
Patient Health Questionnaire-9
Time frame: 12 weeks
Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: 12 weeks
Profile of Mood States
Time frame: 12 weeks
Medical Outcomes Study 36-Item Short Form Health Survey Version 2
Time frame: 12 weeks
Complete metabolic panel
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Lipoprotein Particle Plus (LPP+) Panel
Time frame: 12 weeks
Complete blood count (CBC)
Time frame: 12 weeks
Complete metabolic panel
Time frame: 12 weeks
Measures of weight (kg)
Purdue University
Other
Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function in Adults
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