Status:
COMPLETED
Rapid Effects on Antioxidant Status, Immune Alertness, and Regenerative Activity
Lead Sponsor:
Natural Immune Systems Inc
Conditions:
Immune Surveillance
Stem Cell Surveillance
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This clinical study aims at documenting rapid effects after consuming single doses of test product, when compared to consuming a placebo. A double-blind, placebo-controlled, cross-over study design w...
Detailed Description
For each participant, the clinic visits are scheduled at the same time of the day during the morning hours of 7-11 am to control for the effect of circadian fluctuations. One clinic visit involves con...
Eligibility Criteria
Inclusion
- 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 a 24-hour wash-out period for vitamins and nutritional supplements;
- 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
- 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;
- Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
- Known food allergies related to ingredients in active test product or placebo.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07142720
Start Date
November 1 2022
End Date
July 31 2025
Last Update
August 27 2025
Active Locations (1)
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1
NIS Labs
Klamath Falls, Oregon, United States, 97601