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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mushrooms | Experimental | Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks. |
|
| No Mushrooms | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D-enriched mushrooms | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum 25-hydroxy-vitamin D2 concentration | 25(OH) Vitamin D2/D3 by LC/MS | 12 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Campbell | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University, Department of Nutrition Science | West Lafayette | Indiana | 47907 | United States |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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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.
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| Study Powder | Other | 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. |
|
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |