Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
24 participants
INTERVENTIONAL
2025-09-28
2026-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be consuming placebo or the active nutraceutical blend, separated by a 1-week washout period.
Baseline blood samples are taken 1 hour after participants arrive; the dose is then administered. Additional blood samples are taken 1 hour, 2 hours, and 3 hours following consumption of test product.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Crossover group 1, randomized
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.
Placebo
Four capsules.
Nutraceutical blend
Four capsules.
Experimental: Crossover group 2, randomized
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.
Placebo
Four capsules.
Nutraceutical blend
Four capsules.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Four capsules.
Nutraceutical blend
Four capsules.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Natural Immune Systems Inc
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gitte S. Jensen, PhD
Role: PRINCIPAL_INVESTIGATOR
NIS Labs
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NIS Labs
Klamath Falls, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
058-010
Identifier Type: -
Identifier Source: org_study_id