Clinical Proof-of-concept Study on Immune Surveillance and Alertness
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Immune Surveillance
In brief
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 adults, who will be taking either a placebo or supplement at different times. Testing for immune status, cytokine levels, and immune responsiveness will be conducted to determine the acute impact of the supplement on immune function compared to a placebo. Long term effects and lingering effects will be tested using the same parameters, following a consumption period of one week, as well as a washout period of one week.
Key facts
- Study ID
- NCT05431751
- Run by
- Natural Immune Systems Inc
- People needed
- 24
- Starts
- 2022-07-12
- Expected to finish
- 2023-10-01
- Last updated by the study team
- 2023-08-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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 (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
Where it is running
- NIS Labs — Klamath Falls, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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