Clinical Proof-of-concept Study on Rapid Immune Modulating Effects
NCT ID: NCT05364710
Last Updated: 2022-05-13
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
2022-05-07
2023-06-30
Brief Summary
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Detailed Description
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24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be taking placebo, dose 1, and dose 2, each separated by a 1-week washout period.
Blood samples are taken 1 hour after participants arrive; the dose is then administered. Samples are taken 1 hour, 2 hours, and 24 hours following administration. At each blood sample collection, 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Group A
Crossover study: Participants will be consuming placebo on a clinic day at least 1 week prior to a clinic day where he/she will consume the active intervention.
Transfer factor from colostrum ultrafiltrate
Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.
Group B
Crossover study: Participants will be consuming the active intervention on a clinic day at least 1 week prior to a clinic day where he/she will consume placebo.
Transfer factor from colostrum ultrafiltrate
Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.
Interventions
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Transfer factor from colostrum ultrafiltrate
Proteins that confer immune protection, isolated from cow colostrum ultrafiltrate and used to promote immune health and surveillance.
Eligibility Criteria
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Inclusion Criteria
* Veins easy to see in one or both arms
* Willing to comply with study procedures, including
* Maintaining a consistent diet and lifestyle routine throughout the study;
* Consistent habit of bland breakfast on days of clinic visits
* Abstaining from exercising on 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 Criteria
* Taking anti-inflammatory medications on a daily basis
* Currently experiencing intense stressful events/life changes
* Currently in intensive athletic training (such as marathon runner)
* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel
* An unusual sleep routine
* 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 sensitivities related to ingredients in active test product placebo Prescription medication evaluated on a cas-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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058-006
Identifier Type: -
Identifier Source: org_study_id
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