Clinical trial NCT05431751: Clinical Proof-of-concept Study on Immune Surveillance and Alertness
Official title: Clinical Proof-of-concept Study on Immune Surveillance and Alertness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune Surveillance
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Placebo-controlled, cross-over study design
Primary purpose: BASIC_SCIENCE

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 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.

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 Euglena gracilis algae, produced using a proprietary fermentation technique.

24 subjects will participate in a placebo-controlled, double-blinded, cross-over study design, wherein they will be taking placebo, or dietary supplement each separated by a 1-week washout period to evaluate rapid effects. Following which the subjects will also be taking placebo or dietary supplement continuously for 1 week each, to evaluate the long term and lingering effects.

For acute evaluation, blood samples are taken 1 hour after participants arrive, the dose is then administered. Samples are take 1 hour and 2 hours following administration. For long-term and lingering evaluation, blood samples are taken 1 hour after participants arrive. At all blood sample collections, a spit sample will also be taken for salivary IgA testing.

A series of immune panels will be used to determine the acute impacts on immune surveillance, immune cell activation status, immune cell priming, and cytokine profiles. Ex vivo immune challenges and salivary IgA testing will be used to determine the direct impacts on immune cells.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Immune Surveillance and Alerness
timeFrame: 2 hours, 1 week
Secondary outcomes:
measure: Immune communication
timeFrame: 2 hours, 1 week
Other outcomes:
measure: Immune Responsiveness
timeFrame: 2 hours, 1 week
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
References: