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NCT Number: NCT07127705

Rapid Response of Stem Cells and Immune Cells for Efficacy

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location status: Recruiting

Location contact

Gitte S. Jensen, PhD

CONTACT

[email protected]

541-884-0112

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

2 capsules

Chaga Mushroom

Dietary Supplement

2 capsules

Ginseng extract

Dietary Supplement

2 capsules

Olive Extract

Dietary Supplement

2 capsules

Potassium Hydrogen Glucarate

Dietary Supplement

2 capsules

Primary outcomes

  1. Stem cell trafficking

    Time frame: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug

    Changes to the number of stem cells in the blood circulation (number of cells per mL blood).

    Data is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+.

Secondary outcomes

  1. Mitochondrial volume per cell

    Time frame: Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug

    Mitochondrial volume per cell under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye MitoTracker is used to obtain relative measures of mitochondrial volume per cell using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.

  2. Mitochondrial membrane potential per cell

    Time frame: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug

    Cellular energy production under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye JC-1 is a fluorescent cationic dye used to obtain relative measures of mitochondrial membrane potential per cells, using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Cruickshank

CONTACT

Gitte S. Jensen, PhD

CONTACT

[email protected]

5418820112

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Collaborators

  • Applied Food Sciences Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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