Rapid effects of four products on stem cells, immunity, and cellular energy

Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial

This trial will test whether taking four different products causes rapid changes in stem cell surveillance, immune activation, and mitochondrial energy in healthy adults aged 18 to 75.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Natural Immune Systems Inc (Academic / other)
• Locations: 1 site (Klamath Falls, Oregon)
• Trial ID: NCT07127705 on ClinicalTrials.gov

What this trial studies

This double-blind, placebo-controlled, crossover trial gives each healthy participant four test products and a placebo on separate visits with multiple blood draws to measure immediate responses. Researchers will track stem cell trafficking in the blood and measure mitochondrial energy production and resilience in white blood cells exposed to oxidative and inflammatory stress ex vivo. The products tested are chaga mushroom, ginseng extract, olive extract, and potassium hydrogen glucarate. Participants must follow specific pre-visit routines and have easily accessible veins for repeated blood sampling.

Who should consider this trial

Good fit: Healthy adults aged 18 to 75 with BMI 18.0–34.9, easily visible arm veins, and willingness to follow study diet and clinic visit rules are ideal candidates.

Not a fit: People with prior major gastrointestinal surgery, daily anti-inflammatory medication use, or other exclusion criteria are not eligible and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, these products could offer a simple, fast-acting way to support stem cell surveillance and mitochondrial energy, which may improve immune and recovery responses.

How similar studies have performed: Laboratory and some clinical work suggest natural extracts can affect immune cells and mitochondrial function, but acute crossover human evidence is limited and this specific product combination is relatively untested.

Eligibility criteria

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.

Where this trial is running

Klamath Falls, Oregon

• NIS Labs — Klamath Falls, Oregon, United States (Recruiting)

Study contacts

• Study coordinator: Gitte S. Jensen, PhD

Conditions Stem Cell Surveillance