Rapid Response of Stem Cells and Immune Cells for Efficacy

Natural Immune Systems

Status: Enrolling

Conditions: Stem Cell Surveillance

Treatments: Dietary Supplement: Chaga Mushroom; Dietary Supplement: Placebo; Dietary Supplement: Ginseng extract; Dietary Supplement: Potassium Hydrogen Glucarate; Dietary Supplement: Olive extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07127705

186-006

Details and patient eligibility

About

The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.

Full description

This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.

Data on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults;

• Age 18 - 75 years (inclusive);

• BMI between 18.0 and 34.9 (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 morning 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 (airplane mode is allowed), 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: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups

Crossover group 1, randomized

Experimental group

Description:

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is A, C, B, D, E.

Treatment:

Dietary Supplement: Olive extract

Dietary Supplement: Potassium Hydrogen Glucarate

Dietary Supplement: Ginseng extract

Dietary Supplement: Placebo

Dietary Supplement: Chaga Mushroom

Crossover group 2, randomized

Experimental group

Description:

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is E, A, C, B, D.

Treatment:

Dietary Supplement: Olive extract

Dietary Supplement: Potassium Hydrogen Glucarate

Dietary Supplement: Ginseng extract

Dietary Supplement: Placebo

Dietary Supplement: Chaga Mushroom

Crossover group 3, randomized

Experimental group

Description:

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is D, E, A, C, B.

Treatment:

Dietary Supplement: Olive extract

Dietary Supplement: Potassium Hydrogen Glucarate

Dietary Supplement: Ginseng extract

Dietary Supplement: Placebo

Dietary Supplement: Chaga Mushroom

Crossover group 4, randomized

Experimental group

Description:

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is B, C, D, A, E.

Treatment:

Dietary Supplement: Olive extract

Dietary Supplement: Potassium Hydrogen Glucarate

Dietary Supplement: Ginseng extract

Dietary Supplement: Placebo

Dietary Supplement: Chaga Mushroom