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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05559112
• Other study ID #: IRB-2022-750
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University, Department of Nutrition Science	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum 25-hydroxy-vitamin D2 concentration	25(OH) Vitamin D2/D3 by LC/MS	12 weeks
Secondary	Change in immunity/inflammation markers	Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)	12 weeks
Secondary	Change in immunity/inflammation markers	High Sensitivity C Reactive Protein (hs-CRP)	12 weeks
Secondary	Change in immunity/inflammation markers	Cytokine 13 Panel (pg/mL)	12 weeks
Secondary	Change in bone remodeling	Osteocalcin	12 weeks
Secondary	Change in serum calcium concentrations	Parathyroid hormone (PTH)	12 weeks
Secondary	Change in perceived depression from baseline to mid to post-intervention	Beck's Depression Inventory questionnaire	12 weeks
Secondary	Change in perceived anxiety from baseline to mid to post-intervention	Patient Health Questionnaire-9	12 weeks
Secondary	Change in cognitive function from baseline to mid to post-intervention	Repeatable Battery for the Assessment of Neuropsychological Status	12 weeks
Secondary	Change in perceived daily mood from baseline to mid to post-intervention	Profile of Mood States	12 weeks
Secondary	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
Secondary	Risk factors for cardiovascular disease	Complete metabolic panel	12 weeks
Secondary	Risk factors for cardiovascular disease	Blood pressure	12 weeks
Secondary	Risk factors for cardiovascular disease	Lipoprotein Particle Plus (LPP+) Panel	12 weeks
Secondary	Risk factors for cardiovascular disease	Complete blood count (CBC)	12 weeks
Secondary	Risk factors for type 2 diabetes	Complete metabolic panel	12 weeks
Secondary	Body weight	Measures of weight (kg)	12 weeks