Acute Effects on Stem Cell Surveillance

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stem Cell Surveillance
• Intervention / Treatment: Dietary supplement: Anthocyanin-rich berry extract; Dietary supplement: Anthocyanin-rich flower/leaf extract; Dietary supplement: Berry /leaf blend; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex Cruickshank; Email: Alex@nislabs.com
• Study Contact Backup: Name: Gitte S Jensen, PhD; Phone Number: 541 884 0112; Email: Gitte@nislabs.com

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • NIS Labs
      • Contact: Gitte S. Jensen, PhD; Phone Number: 5418840112; Email: gitte@nislabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crossover Group 1, randomized; Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D.	Dietary supplement: Anthocyanin-rich berry extract; 0.5 grams; Dietary supplement: Anthocyanin-rich flower/leaf extract; 0.5 grams; Dietary supplement: Berry /leaf blend; 0.5 grams; Dietary supplement: Placebo; Placebo (white rice-based)
Experimental: Crossover Group 2, randomized; Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A.	Dietary supplement: Anthocyanin-rich berry extract; 0.5 grams; Dietary supplement: Anthocyanin-rich flower/leaf extract; 0.5 grams; Dietary supplement: Berry /leaf blend; 0.5 grams; Dietary supplement: Placebo; Placebo (white rice-based)
Experimental: Crossover Group 3, randomized; Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B.	Dietary supplement: Anthocyanin-rich berry extract; 0.5 grams; Dietary supplement: Anthocyanin-rich flower/leaf extract; 0.5 grams; Dietary supplement: Berry /leaf blend; 0.5 grams; Dietary supplement: Placebo; Placebo (white rice-based)
Experimental: Crossover Group 4, randomized; Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C.	Dietary supplement: Anthocyanin-rich berry extract; 0.5 grams; Dietary supplement: Anthocyanin-rich flower/leaf extract; 0.5 grams; Dietary supplement: Berry /leaf blend; 0.5 grams; Dietary supplement: Placebo; Placebo (white rice-based)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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+.	Baseline, 1 hour, 2 hours after consumption

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum cytokine levels	Baseline, 1 hour, 2 hours after consumption

Collaborators and Investigators

• Sponsor: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stem cells; Surveillance; Flow cytometry; Mobilization; Homing
• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fruit
• Other Study ID Numbers: 211-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No