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Healthy HumansNCT01398176

Immune Benefits From Mushroom Consumption

A study testing 3 ounces of mushrooms and 6 ounces of mushrooms in people with Healthy Humans, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether consuming mushrooms is effective in enhancing the function of γδ T cells. Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Humans
What is being tested?
3 ounces of mushrooms and 6 ounces of mushrooms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited States
Study dates
Oct 2011to Dec 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or non-pregnant female
  • Between the ages of 21 and 50
  • BMI between 18 and 35

Who cannot join

  • Have illness at the time of enrollment
  • On immunosuppressive drugs, antibiotics, chronic use of NSAIDS
  • Ongoing infection or hypertension that requires medication
  • Consume any flavonoid-containing supplements, antioxidant supplements or probiotics
  • Consume more than 14 glasses of alcoholic beverages per week
  • Consume more than 7 servings of fruits and vegetables per day
  • Are on a strict vegetarian diet
  • Pregnant or lactating women or individuals on hormone therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • 449 Food Science and Human Nutrition Department

    Gainesville, Florida, 32611

Other trials in United States

About this study

The purpose of this study is to determine whether consuming mushrooms is effective in enhancing the function of γδ T cells.

Read the detailed description

A non-therapeutic study is described. This is an intervention study at two levels of mushroom intake. The number of subjects and experimental assays are selected as a pilot study to generate the dose level and the efficacy. Subjects age 21 to 50 will be recruited and provide a baseline blood draw. The mushroom supplementation will occur for 4 weeks at two levels 85 g (3 ounces) and 170 g (6 ounces). Immunity changes fairly rapidly; in and early study the investigators saw changes in as little as 3 days. Blood is taken again at 4 weeks. Peripheral blood mononuclear cells are isolated from the blood and used freshly isolated, or cultured in autologous serum for 24 hours or for 10 days. Freshly isolated cells will be used to count γδ T cell and NK cells baseline values. After 24 hours of stimulation with a broad based mitogen, culture medium is harvested and assayed for cytokines secreted into the culture medium as well as NK cell activation and proliferation. Finally, cells are harvested after 10 days and assayed for γδ T cell activation and proliferation.

Consumers will benefit from knowing that health benefits can be derived from mushrooms. Potentially, this will stimulate mushroom sales and increase the variety of mushrooms consumed.

γδ T cells reside in epithelial linings of the lung, gut and reproductive tract and although their number is not precisely known, they are in much greater numbers than the circulating αβ T cells. γδ T cells are not activated in the same way as the αβ cells, they are activated more like cells of the innate immune system, by recognition of pathogen-associated molecular patterns (1,2). Recognition of pathogen-associated molecular patterns is rather non-specific, but very effective. For example, prenyl phosphate is a molecule having a pattern that is recognized by receptors of the γδ T cells. Interaction of prenyl phosphate with the γδ T cell receptor results in γδ T cell proliferation; expression of cell surface activation markers, such as cytokine receptors; and lastly, synthesis and secretion of cytokines necessary for communicating with other branches of the immune system. The investigators hypothesize that consuming mushrooms will result in greater proliferation when stimulated and will also enhance their capacity for activation, defined here as cytokine secretion and cell surface marker expression.

A second quality of γδ T cells is their ability to turn off the immune response once it is no longer needed. Carding and Egan (3,4) showed that γδ T cells were responsible for killing activated macrophages after the pathogen had been eliminated. Knockout mouse models show that the elimination of γδ cells promote chronic inflammation, prevent wound healing (5) and may increase the risk for cancer (6,7). The magnitude and the importance of the γδ T cell are just being realized. By strengthening γδ T cells, the investigators will fight pathogen better and resolve inflammation quicker.

It is our hypothesis that there are certain bioactive components that resemble pathogen-associated molecular patterns and interact weakly with the epithelial γδ T cells in such a way that they are "primed", but not activated. The bioactive food components do not interact with the cells with enough strength to cause an actual response, but, later, when the cells do encounter pathogen, they can react quicker and with more intensity if they have already been primed. The primary bioactive components in mushrooms that may interact with immune cells are polysaccharides and glycoproteins and the two major types of mushroom polysaccharides include glucans (both β and α) and heteroglycans. Additionally, mushrooms contain another important polysaccharide, chitin. Chitin is composed of N-acetyl-d-glucosamine units (8,9). These compounds are some likely candidates, in addition to other immuno-modulating compounds such as Vitamin D (10) and B vitamins.

Mushrooms have been shown to have an impact on immune cells, particularly NK cells (11,12) but the γδ T cell has not been studied. The composition of mushroom is well suited to interact with the γδ T cell. NK cell activity will be used in this study as a positive control although the investigators will use flow cytometry rather than generalized non-specific cytolytic activity.

The investigators know from our previous studies in humans (7,13,14) and from other published studies (15,16) that foods such as tea, apples, encapsulated fruits and vegetables contain compounds that appear to prime γδ T cells. The investigators hypothesize that bioactive compounds in the gut are recognized by intestinal γδ T cells, resulting in a primed cell. These cells are not static but migrate in and out of tissues, through the circulation as well as lymph nodes (17). Thus, the investigators can measure functional changes in the blood borne γδ T cells regardless of whether the bioactive compound is absorbed or not.

This study will specifically study the shiitake (Lentinus edodes) mushroom. This mushroom has been shown in other research to have a variety of health benefits, but few feeding trials, and none in healthy humans, has been done (18-20).

  1. Specific Aims:

The aim is to determine if bioactive compounds in mushroom can enhance the activity of this cell type. Because this cell type resides in the epithelial linings and migrates via the blood and lymph system, the investigators can measure functional changes in this cell regardless of whether bioactive compounds are absorbed or not. It is often describe as the first line of defense.

Conditions
Healthy Humans
Being tested
3 ounces of mushrooms, 6 ounces of mushrooms
Keywords
gamma delta T cell, proliferation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 ounces of mushroomsDietary supplement

    3 ounces of mushrooms consumed daily for 4 weeks

  • 6 ounces of mushroomsDietary supplement

    6 ounces of mushrooms consumed daily for 4 weeks

Study groups in NCT01398176
Study groupRoleWhat they receive
3 ounces of mushroomsExperimental3 ounces of mushrooms consumed daily for 4 weeks
Receives: Dietary Supplement: 3 ounces of mushrooms
6 ounces of mushroomsExperimental6 ounces of mushrooms consumed daily for 4 weeks
Receives: Dietary Supplement: 6 ounces of mushrooms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiological Modifications to Gamma Delta T Cell Function

    Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T cells express CD3.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMay 2012
  4. Study completionDec 2012

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01398176
Sponsor's protocol ID
MC-95320
Status last verified
Dec 2013
First submitted
18 Jul 2011
Last updated
30 Dec 2013
Data monitoring committee
No

Publications

  • Dai X, Stanilka JM, Rowe CA, Esteves EA, Nieves C Jr, Spaiser SJ, Christman MC, Langkamp-Henken B, Percival SS. Consuming Lentinula edodes (Shiitake) Mushrooms Daily Improves Human Immunity: A Randomized Dietary Intervention in Healthy Young Adults. J Am Coll Nutr. 2015;34(6):478-87. doi: 10.1080/07315724.2014.950391. Epub 2015 Apr 11.

    PubMed 25866155

Questions about this trial

What is this clinical trial studying?

A study testing 3 ounces of mushrooms and 6 ounces of mushrooms in people with Healthy Humans, run by University of Florida 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 3 inclusion and 8 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 30 Dec 2013. 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. 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?

Yes. Results are posted in the registry (first posted 30 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Physiological Modifications to Gamma Delta T Cell Function (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01398176, which also lists 1 linked publication.

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 30 Dec 2013.

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