Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial
| Registry | NCT07127705 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, prevention |
| Enrollment | 24 (Estimated) |
| Sponsor | Natural Immune Systems Inc (Other); collaborators: Applied Food Sciences Inc. |
| Conditions | Stem Cell Surveillance |
| Interventions | Placebo, Chaga Mushroom, Ginseng extract, Olive extract, Potassium Hydrogen Glucarate (Dietary supplement) |
| Dates | start 2025-05-21, primary completion 2025-08-27 (estimated), completion 2025-10-03 (estimated), first posted 2025-08-17, last updated 2025-08-17 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Crossover group 1, randomized | Experimental | Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate | 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. |
| Crossover group 2, randomized | Experimental | Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate | 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. |
| Crossover group 3, randomized | Experimental | Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate | 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. |
| Crossover group 4, randomized | Experimental | Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate | 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. |
Sex: All, ages: 18 Years to 75 Years, 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.
| Facility | City | Country | Status |
|---|---|---|---|
| NIS Labs | Klamath Falls, Oregon | United States | Recruiting |