Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: Vitamin D-enriched mushrooms; Other: Study Powder

• Registration Number: NCT05559112
• Lead Sponsor: Purdue University

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.

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2022-12-05
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mushrooms	Vitamin D-enriched mushrooms	Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks.
No Mushrooms	Study Powder	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.

Primary Outcome Measures

Name	Time	Method
Change in serum 25-hydroxy-vitamin D2 concentration	12 weeks	25(OH) Vitamin D2/D3 by LC/MS

Secondary Outcome Measures

Name	Time	Method
Change in perceived anxiety from baseline to mid to post-intervention	12 weeks	Patient Health Questionnaire-9
Body weight	12 weeks	Measures of weight (kg)
Change in bone remodeling	12 weeks	Osteocalcin
Change in immunity/inflammation markers	12 weeks	Cytokine 13 Panel (pg/mL)
Change in serum calcium concentrations	12 weeks	Parathyroid hormone (PTH)
Change in perceived daily mood from baseline to mid to post-intervention	12 weeks	Profile of Mood States
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 blood count (CBC)
Change in perceived depression from baseline to mid to post-intervention	12 weeks	Beck's Depression Inventory questionnaire
Change in cognitive function from baseline to mid to post-intervention	12 weeks	Repeatable Battery for the Assessment of Neuropsychological Status
Risk factors for type 2 diabetes	12 weeks	Complete metabolic panel

Trial Locations

Locations (1)

Purdue University, Department of Nutrition Science; 🇺🇸 West Lafayette, Indiana, United States