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

Primary Purpose

Vitamin D Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D-enriched mushrooms
Study Powder
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Vitamin D Deficiency focused on measuring Mushroom, Immune function, Vitamin D2, randomized controlled trial

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
  • current with Tetanus vaccination (within pas 9 years)
  • willing to refrain from taking vitaminf D supplements or any supplements containg 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
  • Not vaccinated against Tetanus within the past 9 years
  • Allergic to mushrooms or bread

Sites / Locations

  • Purdue University, Department of Nutrition ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mushrooms

No Mushrooms

Arm Description

Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks.

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.

Outcomes

Primary Outcome Measures

Change in serum 25-hydroxy-vitamin D2 concentration
25(OH) Vitamin D2/D3 by LC/MS

Secondary Outcome Measures

Change in immunity/inflammation markers
Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)
Change in immunity/inflammation markers
High Sensitivity C Reactive Protein (hs-CRP)
Change in immunity/inflammation markers
Cytokine 13 Panel (pg/mL)
Change in bone remodeling
Osteocalcin
Change in serum calcium concentrations
Parathyroid hormone (PTH)
Change in perceived depression from baseline to mid to post-intervention
Beck's Depression Inventory questionnaire
Change in perceived anxiety from baseline to mid to post-intervention
Patient Health Questionnaire-9
Change in cognitive function from baseline to mid to post-intervention
Repeatable Battery for the Assessment of Neuropsychological Status
Change in perceived daily mood from baseline to mid to post-intervention
Profile of Mood States
Change in perceived quality of life from baseline to mid to post-intervention
Medical Outcomes Study 36-Item Short Form Health Survey Version 2
Risk factors for cardiovascular disease
Complete metabolic panel
Risk factors for cardiovascular disease
Blood pressure
Risk factors for cardiovascular disease
Lipoprotein Particle Plus (LPP+) Panel
Risk factors for cardiovascular disease
Complete blood count (CBC)
Risk factors for type 2 diabetes
Complete metabolic panel
Body weight
Measures of weight (kg)

Full Information

First Posted
September 26, 2022
Last Updated
February 14, 2023
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT05559112
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Mushroom, Immune function, Vitamin D2, randomized controlled trial

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mushrooms
Arm Type
Experimental
Arm Description
Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks.
Arm Title
No Mushrooms
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vitamin D-enriched mushrooms
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Study Powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in serum 25-hydroxy-vitamin D2 concentration
Description
25(OH) Vitamin D2/D3 by LC/MS
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in immunity/inflammation markers
Description
Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)
Time Frame
12 weeks
Title
Change in immunity/inflammation markers
Description
High Sensitivity C Reactive Protein (hs-CRP)
Time Frame
12 weeks
Title
Change in immunity/inflammation markers
Description
Cytokine 13 Panel (pg/mL)
Time Frame
12 weeks
Title
Change in bone remodeling
Description
Osteocalcin
Time Frame
12 weeks
Title
Change in serum calcium concentrations
Description
Parathyroid hormone (PTH)
Time Frame
12 weeks
Title
Change in perceived depression from baseline to mid to post-intervention
Description
Beck's Depression Inventory questionnaire
Time Frame
12 weeks
Title
Change in perceived anxiety from baseline to mid to post-intervention
Description
Patient Health Questionnaire-9
Time Frame
12 weeks
Title
Change in cognitive function from baseline to mid to post-intervention
Description
Repeatable Battery for the Assessment of Neuropsychological Status
Time Frame
12 weeks
Title
Change in perceived daily mood from baseline to mid to post-intervention
Description
Profile of Mood States
Time Frame
12 weeks
Title
Change in perceived quality of life from baseline to mid to post-intervention
Description
Medical Outcomes Study 36-Item Short Form Health Survey Version 2
Time Frame
12 weeks
Title
Risk factors for cardiovascular disease
Description
Complete metabolic panel
Time Frame
12 weeks
Title
Risk factors for cardiovascular disease
Description
Blood pressure
Time Frame
12 weeks
Title
Risk factors for cardiovascular disease
Description
Lipoprotein Particle Plus (LPP+) Panel
Time Frame
12 weeks
Title
Risk factors for cardiovascular disease
Description
Complete blood count (CBC)
Time Frame
12 weeks
Title
Risk factors for type 2 diabetes
Description
Complete metabolic panel
Time Frame
12 weeks
Title
Body weight
Description
Measures of weight (kg)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luz Componi
Phone
630-344-9402
Email
lcomboni@purdue.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Harrison Cottingham
Phone
812-606-2211
Email
hcotting@purdue.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Campbell
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University, Department of Nutrition Science
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luz Comboni
Email
lcomboni@purdue.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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