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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: Vitamin D-enriched mushrooms; Other: Study Powder

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University, Department of Nutrition Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mushrooms; Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks.	Other: Vitamin 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.
Placebo Comparator: No Mushrooms; 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.	Other: Study 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum 25-hydroxy-vitamin D2 concentration	25(OH) Vitamin D2/D3 by LC/MS	12 weeks

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Purdue University
• Investigators: Principal Investigator: Wayne Campbell, Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; Vitamin D2; Immune function; Mushroom
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: IRB-2022-750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No