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

NCT05559112 | Completed

• 1 other identifier: IRB-2022-750
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Mushroom; Immune function; Vitamin D2; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in serum 25-hydroxy-vitamin D2 concentration

  25(OH) Vitamin D2/D3 by LC/MS

  12 weeks

Secondary Outcomes (16)

• Change in immunity/inflammation markers

  12 weeks

• Change in immunity/inflammation markers

  12 weeks

• Change in immunity/inflammation markers

  12 weeks

• Change in bone remodeling

  12 weeks

• Change in serum calcium concentrations

  12 weeks

Study Arms (2)

Mushrooms

EXPERIMENTAL

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

No Mushrooms

PLACEBO COMPARATOR

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

Interventions

Vitamin D-enriched mushrooms 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.

Mushrooms

Study Powder 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.

No Mushrooms

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University, Department of Nutrition Science

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Wayne Campbell

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: December 5, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

US (1)