Acute Effects on Stem Cell Surveillance

Trial statusNot yet recruiting
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 acute immune effects of three nutraceutical ingredients and blends to a placebo.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults;

Age 18-75 years (inclusive);

Veins easy to see in one or both arms (to allow for the multiple blood draws);

Maintaining a consistent diet and lifestyle routine throughout the study,

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

  • Anthocyanin-rich berry extract

    Dietary supplement

    0.5 grams

  • Anthocyanin-rich flower/leaf extract

    Dietary supplement

    0.5 grams

  • Berry /leaf blend

    Dietary supplement

    0.5 grams

  • Placebo

    Dietary supplement

    Placebo (white rice-based)

Treatment groups

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

Trial outcomes

Primary outcomes

1

Stem cell surveillance

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 after consumption

Secondary outcomes

1

Serum cytokine levels

Time frame
Baseline, 1 hour, 2 hours after consumption

Other outcomes

Sponsors and contacts

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