Clinical Proof-of-concept Study on Immune Surveillance and Alertness
NCT ID: NCT05431751
Last Updated: 2023-08-07
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
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2022-07-12
2023-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Experimental Group A
Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where they will consume the active intervention. Following the second clinic day, the participant will consume active intervention for 7 days. The participant will then undergo a washout period of 7 days.
Whole Algae
Whole Euglena gracilis algae, produced by proprietary fermentation.
Interventions
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Whole Algae
Whole Euglena gracilis algae, produced by proprietary fermentation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Natural Immune Systems Inc
OTHER
Responsible Party
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Locations
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NIS Labs
Klamath Falls, Oregon, United States
Countries
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Facility Contacts
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Other Identifiers
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153-012
Identifier Type: -
Identifier Source: org_study_id
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