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

NCT ID: NCT05559112

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2024-04-30

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Mushrooms

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

Group Type: EXPERIMENTAL

Vitamin D-enriched mushrooms

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Study Powder

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne Campbell

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University, Department of Nutrition Science

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

IRB-2022-750

Identifier Type: -

Identifier Source: org_study_id