Rapid Response of Stem Cells and Immune Cells for Efficacy

NCT07127705 | Recruiting

• 1 other identifier: 186-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stem Cell Surveillance

Outcome Measures

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+.

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

Secondary Outcomes (2)

• Mitochondrial volume per cell

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

• Mitochondrial membrane potential per cell

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

Study Arms (4)

Crossover group 1, randomized

EXPERIMENTAL

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is A, C, B, D, E.

Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate

Crossover group 2, randomized

EXPERIMENTAL

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is E, A, C, B, D.

Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate

Crossover group 3, randomized

EXPERIMENTAL

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is D, E, A, C, B.

Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate

Crossover group 4, randomized

EXPERIMENTAL

Crossover study: Participants consume a test product on each of the five clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 4 active test products versus placebo over 5 weeks. The order of interventions for this group is B, C, D, A, E.

Dietary Supplement: Placebo; Dietary Supplement: Chaga Mushroom; Dietary Supplement: Ginseng extract; Dietary Supplement: Olive extract; Dietary Supplement: Potassium Hydrogen Glucarate

Interventions

Placebo DIETARY_SUPPLEMENT

2 capsules

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

Chaga Mushroom DIETARY_SUPPLEMENT

2 capsules

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

Ginseng extract DIETARY_SUPPLEMENT

2 capsules

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

Olive extract DIETARY_SUPPLEMENT

2 capsules

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

Potassium Hydrogen Glucarate DIETARY_SUPPLEMENT

2 capsules

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);
• BMI between 18.0 and 34.9 (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 (airplane mode is allowed), 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 antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
• 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.

Sponsors & Collaborators

• Natural Immune Systems Inc: lead
• Applied Food Sciences Inc.: collaborator

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

MeSH Terms

Interventions

Asian ginseng; olive extract; potassium hydrogen glucarate

Central Study Contacts

Gitte S. Jensen, PhD

CONTACT

5418820112; Gitte@nislabs.com

Alex Cruickshank

CONTACT

Study Design

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

Model Details: Placebo-controlled, randomized, double-blinded, cross-over study design.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: August 17, 2025
• Study Start: May 21, 2025
• Primary Completion: August 27, 2025
• Study Completion: October 3, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)