Skip to main content
OpenTrials
Completed

NCT Number: NCT05559112

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University, Department of Nutrition Science

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in serum 25-hydroxy-vitamin D2 concentration

    Time frame: 12 weeks

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

Secondary outcomes

  1. Change in immunity/inflammation markers

    Time frame: 12 weeks

    Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)

  2. Change in immunity/inflammation markers

    Time frame: 12 weeks

    High Sensitivity C Reactive Protein (hs-CRP)

  3. Change in immunity/inflammation markers

    Time frame: 12 weeks

    Cytokine 13 Panel (pg/mL)

  4. Change in bone remodeling

    Time frame: 12 weeks

    Osteocalcin

  5. Change in serum calcium concentrations

    Time frame: 12 weeks

    Parathyroid hormone (PTH)

  6. Change in perceived depression from baseline to mid to post-intervention

    Time frame: 12 weeks

    Beck's Depression Inventory questionnaire

  7. Change in perceived anxiety from baseline to mid to post-intervention

    Time frame: 12 weeks

    Patient Health Questionnaire-9

  8. Change in cognitive function from baseline to mid to post-intervention

    Time frame: 12 weeks

    Repeatable Battery for the Assessment of Neuropsychological Status

  9. Change in perceived daily mood from baseline to mid to post-intervention

    Time frame: 12 weeks

    Profile of Mood States

  10. Change in perceived quality of life from baseline to mid to post-intervention

    Time frame: 12 weeks

    Medical Outcomes Study 36-Item Short Form Health Survey Version 2

  11. Risk factors for cardiovascular disease

    Time frame: 12 weeks

    Complete metabolic panel

  12. Risk factors for cardiovascular disease

    Time frame: 12 weeks

    Blood pressure

  13. Risk factors for cardiovascular disease

    Time frame: 12 weeks

    Lipoprotein Particle Plus (LPP+) Panel

  14. Risk factors for cardiovascular disease

    Time frame: 12 weeks

    Complete blood count (CBC)

  15. Risk factors for type 2 diabetes

    Time frame: 12 weeks

    Complete metabolic panel

  16. Body weight

    Time frame: 12 weeks

    Measures of weight (kg)

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2022
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.