Status:
UNKNOWN
Clinical Proof-of-concept Study on Immune Surveillance and Alertness
Lead Sponsor:
Natural Immune Systems Inc
Conditions:
Immune Surveillance
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Clinical proof-of-concept study comparing the acute. effects of an algae-based dietary supplement on immune surveillance and alertness. This study involves twenty-four participants composed of healthy...
Detailed Description
Clinical-proof-of-concept study comparing the acute immune effects as well as the lasting and lingering effects of a dietary supplement, and a placebo. The dietary supplement is composed of whole Eugl...
Eligibility Criteria
Inclusion
- Healthy adults
- Veins easy to see in both arms
- Willing to comply with a 24-hours 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, tobacco use, 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
- Willing to abstain from music, candy, gum, computer/cellphone 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 (81 mg aspirin is acceptable)
- Vaccination during past 2 weeks
- 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)
- Unwilling to maintain a constant intake of supplements over the duration of the study
- Anxiety about having blood drawn
- People of childbearing potential: Pregnant, nursing, or trying to become pregnant
- Known food allergies or sensitivities related to the test product or placebo
- Prescription medication will be evaluated on a case-by-case basis
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05431751
Start Date
July 12 2022
End Date
October 1 2023
Last Update
August 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NIS Labs
Klamath Falls, Oregon, United States, 97601