Medicinal Mushrooms for Immune Surveillance

Overseen By Gitte S Jensen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Natural Immune Systems Inc

Must not be taking: Antipsychotics, Anti-inflammatories

Disqualifiers: Major gastrointestinal surgery, Intense stress, Intensive athletic training, Unusual sleep routine, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effects of three types of medicinal mushrooms—Agaricus, Reishi, and Turkey Tail—on the immune system against a placebo. The study employs a crossover design, allowing participants to try each mushroom and a placebo at different times. It suits healthy adults with easily visible veins who are willing to adhere to specific diet and lifestyle guidelines during the study. As an unphased trial, participants can contribute to foundational research on natural immune system enhancers.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications. The trial excludes people taking daily anti-inflammatory or antipsychotic medications. If you're on these, you might not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mushrooms like Agaricus, Reishi, and Turkey Tail offer health benefits. They can strengthen the immune system and are often available as supplements. However, many of these mushrooms have not undergone comprehensive safety testing with modern methods.

These mushrooms have a long history in traditional medicine, suggesting potential safety, but this differs from detailed scientific testing. So far, studies have not reported any major harmful side effects.

Since this trial is not in its early stages, there might be less direct evidence about safety. This should be considered when deciding whether to join. Participants should be aware that while these mushrooms are popular, more safety information is still needed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring medicinal mushrooms for boosting immune surveillance because these natural substances might interact with the immune system in unique ways. Unlike traditional treatments that often rely on synthetic drugs, medicinal mushrooms contain bioactive compounds that could enhance the body's innate ability to detect and fight off pathogens. This natural approach offers a novel mechanism of action compared to conventional medications, potentially leading to fewer side effects and an overall boost in immune health.

What evidence suggests that this trial's treatments could be effective for immune surveillance?

Research suggests that medicinal mushrooms like Agaricus, Reishi, and Turkey Tail might help strengthen the immune system. Studies in mice have shown that these mushrooms can increase the growth of white blood cells and levels of a protein called IgG, both crucial for fighting infections. Additionally, these mushrooms may enhance chemotherapy effectiveness while protecting the bone marrow. Some evidence indicates they might help balance the immune system, which is useful in conditions where it is overly active. However, they could potentially overstimulate the immune system in people taking certain medications. Overall, these mushrooms show promise for supporting immune health. Participants in this trial will consume different combinations of these medicinal mushrooms and a placebo in a crossover design to evaluate their effects on immune surveillance. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This clinical trial is open to individuals interested in studying the immune effects of medicinal mushrooms. Specific eligibility criteria for inclusion or exclusion are not provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

Willing to comply with study procedures, including maintaining a consistent diet and lifestyle routine throughout the study, having a consistent habit of bland breakfasts on days of clinic visits, abstaining from exercising and nutritional supplements on the morning of a study visit, abstaining from the use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit, and abstaining from music, candy, gum, computer/cell phone use during clinic visits.

I am a healthy adult.

I am between 18 and 75 years old.

Exclusion Criteria

Currently experiencing intense stressful events/life changes

Currently in intensive athletic training (such as marathon runners)

Having an unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a test product on each of the four clinic days, with a 1-week wash-out period between each product, over 4 weeks.

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for immune responsiveness and communication after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medicinal Mushrooms

Trial Overview The trial is testing the immune modulating effects of three types of medicinal mushrooms: Turkey Tail, Reishi, and Agaricus blazei. Participants will be randomly assigned to receive one of these mushrooms or a placebo to compare their effects on immune function.

How Is the Trial Designed?

Group I: Crossover group 4, randomized Experimental Treatment 4 Interventions

Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is D, B, A, C.

Group II: Crossover group 3, randomized Experimental Treatment 4 Interventions

Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is C, A, D, B.

Group III: Crossover group 2, randomized Experimental Treatment 4 Interventions

Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is B, D, A, C.

Group IV: Crossover group 1, randomized Experimental Treatment 4 Interventions

Crossover study: Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 4 weeks. The order of interventions for this group is A, B, C, D.

Who Is Running the Clinical Trial?

Natural Immune Systems Inc

Lead Sponsor

Trials

20

Recruited

510+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7826851/

Medicinal Mushrooms: Bioactive Compounds, Use, and ... Studies in vitro or in mice models have shown an increase in lymphocyte proliferation and immunoglobulin IgG levels, suggesting effects on humoral immunity by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4684115/

Immune Modulation From Five Major Mushrooms Additionally, evidence suggests that medicinal mushrooms may safely boost chemotherapeutic efficacy and simultaneously protect against bone marrow suppression.

3. mskcc.org mskcc.org/news/do-mushroom-supplements-boost-immunity-against-cancer

Do Mushroom Supplements Boost Immunity Against Cancer? For patients on immunotherapy, mushrooms can overstimulate the immune system and make side effects worse. For patients on immune suppressants ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0896841120302092

Mushrooms and immunity Mushrooms and/or their extracts have been advocated as potential immune modulators, including for immunotherapy, treatment of cancer and immune regulation in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07195552

Clinical Trial: Rapid Immune Modulating Effects The goal for this clinical trial is to compare acute immune effects of three different medicinal mushrooms to a placebo in a healthy population.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0278691517300984

Safety assessment of mushrooms in dietary supplements ... In general, many medicinal mushrooms have not been evaluated for their safe human use using modern analytical approaches. While history of use data should be ...

7. cancer.gov cancer.gov/about-cancer/treatment/cam/hp/mushrooms-pdq

Medicinal Mushrooms (PDQ®)–Health Professional Version Medicinal mushrooms, used for infections, have been used in cancer treatment. They stimulate immune cells, and are sold as supplements, but not ...

8. libres.uncg.edu libres.uncg.edu/ir/uncg/f/N_Oberlies_Safety_2017.pdf

Safety Assessment of Mushrooms in Dietary Supplements ... Despite growing popularity in dietary supplements, many medicinal mushrooms have not been evaluated for their safe human consumption using ...