NCT07206407

Brief Summary

The goal for this clinical trial is to document rapid effects of a nutritional blend on immune cells. A double-blind, placebo-controlled, cross-over study design will be used.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

September 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 17, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 10, 2025

Last Update Submit

December 15, 2025

Conditions

Immune Surveillance

Outcome Measures

Primary Outcomes (1)

  • Immune cell surveillance

    Observation of changes in immune cell trafficking, i.e., the changes in immune cell numbers in the peripheral blood following administration. Data is collected as 'cell numbers per uL whole blood' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * non-NK nonT cells

    3 hours after consuming a test product for this study protocol

Secondary Outcomes (1)

  • Immune cell activation status

    3 hours after consuming a test product for this study protocol

Study Arms (2)

Experimental: Crossover group 1, randomized

EXPERIMENTAL

Crossover study: Participants consume a test product on each of the two clinic visits, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume the active test product versus placebo over 2 weeks. The order of interventions for this group is A, B.

Dietary Supplement: PlaceboDietary Supplement: Nutraceutical blend

Experimental: Crossover group 2, randomized

EXPERIMENTAL

Crossover study: Participants consume a test product on each of the two clinic visits, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume the active test product versus placebo over 2 weeks. The order of interventions for this group is B, A.

Dietary Supplement: PlaceboDietary Supplement: Nutraceutical blend

Interventions

PlaceboDIETARY_SUPPLEMENT

Four capsules.

Experimental: Crossover group 1, randomizedExperimental: Crossover group 2, randomized
Nutraceutical blendDIETARY_SUPPLEMENT

Four capsules.

Experimental: Crossover group 1, randomizedExperimental: Crossover group 2, randomized

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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 allergies related to ingredients in active test product or placebo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

Study Officials

  • Gitte S. Jensen, PhD

    NIS Labs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitte S. Jensen, PhD

CONTACT

15418840112gitte@nislabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Participants will not be informed on which intervention they consume on a given clinic visit.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Double-blinded, placebo-controlled, cross-over study design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

October 3, 2025

Study Start

September 28, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)