Acute Effects on Stem Cell Surveillance

NCT07341178 | Not Yet Recruiting

• 1 other identifier: 211-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stem Cell Surveillance

Keywords

Stem cells; Flow cytometry; Surveillance; Mobilization; Homing

Outcome Measures

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+.

  Baseline, 1 hour, 2 hours after consumption

Secondary Outcomes (1)

• Serum cytokine levels

  Baseline, 1 hour, 2 hours after consumption

Study Arms (4)

Crossover Group 1, randomized

EXPERIMENTAL

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; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo

Crossover Group 2, randomized

EXPERIMENTAL

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; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo

Crossover Group 3, randomized

EXPERIMENTAL

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; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo

Crossover Group 4, randomized

EXPERIMENTAL

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; Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Berry /leaf blend; Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo (white rice-based)

Crossover Group 1, randomized; Crossover Group 2, randomized; Crossover Group 3, randomized; Crossover Group 4, randomized

Anthocyanin-rich berry extract DIETARY_SUPPLEMENT

0.5 grams

Crossover Group 1, randomized; Crossover Group 2, randomized; Crossover Group 3, randomized; Crossover Group 4, randomized

Anthocyanin-rich flower/leaf extract DIETARY_SUPPLEMENT

0.5 grams

Crossover Group 1, randomized; Crossover Group 2, randomized; Crossover Group 3, randomized; Crossover Group 4, randomized

Berry /leaf blend DIETARY_SUPPLEMENT

0.5 grams

Crossover Group 1, randomized; Crossover Group 2, randomized; Crossover Group 3, randomized; Crossover Group 4, randomized

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Gitte S Jensen, PhD

CONTACT

541 884 0112; Gitte@nislabs.com

Alex Cruickshank

CONTACT

Alex@nislabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, acute cross-over study design.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)