Health TrialsbyHealthPanel

Rapid Response of Stem Cells and Immune Cells for Efficacy

ConditionStem Cell Surveillance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNatural Immune Systems Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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);

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Crossover group 1, randomizedExperimental treatment 5 interventions
Group B: Crossover group 2, randomizedExperimental treatment 5 interventions
Group C: Crossover group 3, randomizedExperimental treatment 5 interventions
Group D: Crossover group 4, randomizedExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Stem cell trafficking

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+.

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

Secondary outcomes

1

Mitochondrial volume per cell

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.

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

Mitochondrial membrane potential per cell

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Natural Immune Systems Inc

Lead sponsor

Applied Food Sciences Inc.

Collaborator

Source ClinicalTrials.gov
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