Vitamin D DeficiencyNCT05559112
Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults
A study testing Vitamin D-enriched mushrooms and Study Powder in people with Vitamin D Deficiency, run by Purdue University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D-enriched mushrooms and Study Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University, Department of Nutrition Science
West Lafayette, Indiana, 47907
About this study
Official title: Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function 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.
Read the 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
- Being tested
- Vitamin D-enriched mushrooms, Study Powder
- Keywords
- Mushroom, Immune function, Vitamin D2, randomized controlled trial
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D-enriched mushroomsOther
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 PowderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mushrooms | Experimental | Participants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks. Receives: 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. Receives: Other: Study Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum 25-hydroxy-vitamin D2 concentration
25(OH) Vitamin D2/D3 by LC/MS
Measured: 12 weeks
Secondary outcomes (16)
Change in immunity/inflammation markers
Immunoglobulin G, Immunoglobulin A, Immunoglobulin M (mg/dL)
Measured: 12 weeks
Change in immunity/inflammation markers
High Sensitivity C Reactive Protein (hs-CRP)
Measured: 12 weeks
Change in immunity/inflammation markers
Cytokine 13 Panel (pg/mL)
Measured: 12 weeks
Change in bone remodeling
Osteocalcin
Measured: 12 weeks
Change in serum calcium concentrations
Parathyroid hormone (PTH)
Measured: 12 weeks
Change in perceived depression from baseline to mid to post-intervention
Beck's Depression Inventory questionnaire
Measured: 12 weeks
Change in perceived anxiety from baseline to mid to post-intervention
Patient Health Questionnaire-9
Measured: 12 weeks
Change in cognitive function from baseline to mid to post-intervention
Repeatable Battery for the Assessment of Neuropsychological Status
Measured: 12 weeks
Change in perceived daily mood from baseline to mid to post-intervention
Profile of Mood States
Measured: 12 weeks
Change in perceived quality of life from baseline to mid to post-intervention
Medical Outcomes Study 36-Item Short Form Health Survey Version 2
Measured: 12 weeks
Risk factors for cardiovascular disease
Complete metabolic panel
Measured: 12 weeks
Risk factors for cardiovascular disease
Blood pressure
Measured: 12 weeks
Risk factors for cardiovascular disease
Lipoprotein Particle Plus (LPP+) Panel
Measured: 12 weeks
Risk factors for cardiovascular disease
Complete blood count (CBC)
Measured: 12 weeks
Risk factors for type 2 diabetes
Complete metabolic panel
Measured: 12 weeks
Body weight
Measures of weight (kg)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start5 Dec 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne Campbell, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559112
- Sponsor's protocol ID
- IRB-2022-750
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function in Adults
- ClinicalTrials.gov ID
- NCT05559112
- Acronym / sponsor ID
- IRB-2022-750
- Conditions
- Vitamin D Deficiency
- Keywords
- Mushroom, Immune function, Vitamin D2, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mushrooms | Experimental | Other: Vitamin D-enriched mushroomsParticipants will consume their usual, unrestricted, self-selected diet plus 84 g of vitamin D-enriched mushrooms twice daily for 12 weeks. |
| No Mushrooms | Placebo comparator | Other: Study PowderThis 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. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D-enriched mushroomsParticipants 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. | Other | Mushrooms |
| Study PowderParticipants 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. | Other | No Mushrooms |
Primary outcome
Change in serum 25-hydroxy-vitamin D2 concentration
Time frame: 12 weeks
25(OH) Vitamin D2/D3 by LC/MS
16 secondary outcomes
Change in immunity/inflammation markers
Time frame: 12 weeks
Change in immunity/inflammation markers
Time frame: 12 weeks
Change in immunity/inflammation markers
Time frame: 12 weeks
Change in bone remodeling
Time frame: 12 weeks
Change in serum calcium concentrations
Time frame: 12 weeks
Change in perceived depression from baseline to mid to post-intervention
Time frame: 12 weeks
Change in perceived anxiety from baseline to mid to post-intervention
Time frame: 12 weeks
Change in cognitive function from baseline to mid to post-intervention
Time frame: 12 weeks
Change in perceived daily mood from baseline to mid to post-intervention
Time frame: 12 weeks
Change in perceived quality of life from baseline to mid to post-intervention
Time frame: 12 weeks
Risk factors for cardiovascular disease
Time frame: 12 weeks
Risk factors for cardiovascular disease
Time frame: 12 weeks
Risk factors for cardiovascular disease
Time frame: 12 weeks
Risk factors for cardiovascular disease
Time frame: 12 weeks
Risk factors for type 2 diabetes
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Campbell principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D-enriched mushrooms and Study Powder in people with Vitamin D Deficiency, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum 25-hydroxy-vitamin D2 concentration (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.