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NCT05559112 | Active, not recruiting | Vitamin D Deficiency

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

Purdue University

Information provided by (Responsible Party):

Wayne Campbell

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.

Condition or disease

Vitamin D Deficiency

Intervention/treatment

Vitamin D-enriched mushrooms

Study Powder

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking : Single
Primary Purpose : Screening
Official Title : Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function in Adults
Actual Study Start Date : December 5, 2022
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024
Arm Intervention/treatment

Experimental: Mushrooms

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

Placebo Comparator: 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.

Other: Study Powder
Ages Eligible for Study: 30 Years to 69 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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
Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults

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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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Locations

Not yet recruiting

United States, Indiana

Purdue University, Department of Nutrition Science

West Lafayette, Indiana, United States, 47907