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NCT Number: NCT07341178

Acute Effects on Stem Cell Surveillance

The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The goal for this clinical trial is to compare acute immune effects of anthocyanin-rich botanical extracts and blends to a placebo.

Stem cell mobilization and homing will be evaluated through monitoring of changes to the numbers of various types of stem cells in the blood circulation.

The testing will show whether consuming the active test products lead to changes in stem cell numbers in circulation above the normal circadian changes for each participant. The normal circadian changes are documented on the clinic visit where placebo is consumed. Several different stem cell populations will be evaluated using flow cytometry.

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);
  • 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, 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 anxiolytic, hypnotic, or anti-depressant prescription medication;
  • 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.

Prescription medication will be evaluated on a case-by-case basis.

Treatment and study plan

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)

Primary outcomes

  1. Stem cell surveillance

    Time frame: Baseline, 1 hour, 2 hours after consumption

    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. Serum cytokine levels

    Time frame: Baseline, 1 hour, 2 hours after consumption

Study contacts

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

Alex Cruickshank

CONTACT

[email protected]

Gitte S Jensen, PhD

CONTACT

[email protected]

541 884 0112

Sponsors and collaborators

Lead sponsor

Natural Immune Systems Inc

Other

Registry information

Official study title

Clinical Trial on Rapid Effects on Stem Cell Surveillance. A Randomized Placebo-controlled Acute Cross-over Trial.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

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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