Clinical Trial on Rapid Immune Modulating Effects
ConditionImmune Surveillance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNatural Immune Systems Inc
About this trial
The goal for this clinical trial is to document rapid effects of a nutritional blend on immune cells. A double-blind, placebo-controlled, cross-over study design will be used.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults;
Age 18-75 years (inclusive);
Veins easy to see in one or both arms (to allow for the multiple blood draws);
Maintaining a consistent diet and lifestyle routine throughout the study,
Disqualifiers
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;
Currently experiencing intense stressful events/ life changes;
Currently in intensive athletic training (such as marathon runners);
Trial design
Design model
Crossover
Treatments tested in this trial
Placebo
Dietary supplementFour capsules.
Nutraceutical blend
Dietary supplementFour capsules.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Experimental: Crossover group 1, randomizedExperimental treatment 2 interventions
Group B: Experimental: Crossover group 2, randomizedExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Immune cell surveillance
Observation of changes in immune cell trafficking, i.e., the changes in immune cell numbers in the peripheral blood following administration. Data is collected as 'cell numbers per uL whole blood' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * non-NK nonT cells
Time frame
3 hours after consuming a test product for this study protocolSecondary outcomes
1
Immune cell activation status
Observation of immune cell status of alertness, i.e., the changes in the expression of CD25 and CD69. Data is collected as 'mean fluorescence intensity' for the following immune cell types: * Monocytes * NK cells * NKT cells * T cells * nonNK nonT cells
Time frame
3 hours after consuming a test product for this study protocolSponsors and contacts
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Source ClinicalTrials.gov