Clinical trial NCT05559112: Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults
Official title: Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Mushroom
Immune function
Vitamin D2
randomized controlled trial
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum 25-hydroxy-vitamin D2 concentration
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in immunity/inflammation markers
timeFrame: 12 weeks
measure: Change in immunity/inflammation markers
timeFrame: 12 weeks
measure: Change in immunity/inflammation markers
timeFrame: 12 weeks
measure: Change in bone remodeling
timeFrame: 12 weeks
measure: Change in serum calcium concentrations
timeFrame: 12 weeks
measure: Change in perceived depression from baseline to mid to post-intervention
timeFrame: 12 weeks
measure: Change in perceived anxiety from baseline to mid to post-intervention
timeFrame: 12 weeks
measure: Change in cognitive function from baseline to mid to post-intervention
timeFrame: 12 weeks
measure: Change in perceived daily mood from baseline to mid to post-intervention
timeFrame: 12 weeks
measure: Change in perceived quality of life from baseline to mid to post-intervention
timeFrame: 12 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 12 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 12 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 12 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 12 weeks
measure: Risk factors for type 2 diabetes
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University, Department of Nutrition Science
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne Campbell
role: PRINCIPAL_INVESTIGATOR
References: