Clinical Trial: Rapid Immune Modulating Effects

Natural Immune Systems

Status: Enrolling

Conditions: Immune Surveillance

Treatments: Dietary Supplement: Reishi; Dietary Supplement: Agaricus blazei; Dietary Supplement: Turkey Tail; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07195552

171-003

Details and patient eligibility

About

The goal for this clinical trial is to compare the immune effects of three different medicinal mushrooms to a placebo. The mushrooms include Agaricus, Reishi, and Turkey Tail.

Full description

The goal for this clinical trial is to compare acute immune effects of three different medicinal mushrooms to a placebo in a healthy population. The mushrooms include Agaricus, Reishi, and Turkey Tail.

The outcomes include immune cell communication via pro- and anti-inflammatory cytokines, increased immune cell alertness, and immune cell trafficking and surveillance.

These activities happen normally as part of our immune system's circadian cycles and can be significantly enhanced by consuming nutraceutical products.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults;
• Age 18-75 years (inclusive);
• Veins easy to see in one or both arms (to allow for the multiple blood draws);
• Willing to comply with study procedures, including:
• Maintaining a consistent diet and lifestyle routine throughout the study,
• Consistent habit of bland breakfasts on days of clinic visits,
• Abstaining from exercising and nutritional supplements on the morn ing of a study visit,
• Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;
• Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion criteria

• Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
• Taking anti-inflammatory medications on a daily basis;
• Currently experiencing intense stressful events/ life changes;
• Currently in intensive athletic training (such as marathon runners);
• Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
• An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
• Unwilling to maintain a constant intake of supplements over the duration of the study;
• Anxiety about having blood drawn;
• Pregnant, nursing, or trying to become pregnant;
• Known food allergies related to ingredients in active test product or placebo.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 4 patient groups

Crossover group 1, randomized

Experimental group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: Turkey Tail

Dietary Supplement: Reishi

Dietary Supplement: Agaricus blazei

Crossover group 2, randomized

Experimental group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: Turkey Tail

Dietary Supplement: Reishi

Dietary Supplement: Agaricus blazei

Crossover group 3, randomized

Experimental group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: Turkey Tail

Dietary Supplement: Reishi

Dietary Supplement: Agaricus blazei

Crossover group 4, randomized

Experimental group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: Turkey Tail

Dietary Supplement: Reishi

Dietary Supplement: Agaricus blazei