Vitamin D Deficiency
Conditions
Keywords
Mushroom, Immune function, Vitamin D2, randomized controlled trial
Brief summary
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
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.
Interventions
OTHERVitamin D-enriched mushrooms
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.
OTHERStudy Powder
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.
Sponsors
Purdue University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum 25-hydroxy-vitamin D2 concentration | 12 weeks | 25(OH) Vitamin D2/D3 by LC/MS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bone remodeling | 12 weeks | Osteocalcin |
| Change in serum calcium concentrations | 12 weeks | Parathyroid hormone (PTH) |
| Change in perceived depression from baseline to mid to post-intervention | 12 weeks | Beck's Depression Inventory questionnaire |
| Change in perceived anxiety from baseline to mid to post-intervention | 12 weeks | Patient Health Questionnaire-9 |
| Change in cognitive function from baseline to mid to post-intervention | 12 weeks | Repeatable Battery for the Assessment of Neuropsychological Status |
| Change in immunity/inflammation markers | 12 weeks | Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL) |
| Change in perceived quality of life from baseline to mid to post-intervention | 12 weeks | Medical Outcomes Study 36-Item Short Form Health Survey Version 2 |
| Risk factors for cardiovascular disease | 12 weeks | Complete metabolic panel |
| Risk factors for type 2 diabetes | 12 weeks | Complete metabolic panel |
| Body weight | 12 weeks | Measures of weight (kg) |
| Change in perceived daily mood from baseline to mid to post-intervention | 12 weeks | Profile of Mood States |
Countries
United States
Outcome results
None listed