Controlling the Study Environment

The immune system is highly sensitive to stressors. Controlling the study environment is especially important when conducting studies aimed at collecting data on inflammation and immune support.  It is also important to control for factors such as circadian cycles and sleep.

In order to minimize potential anxiety and stress, which confounds the data during such a study, study participants should be made familiar with the clinic, staff, and procedures prior to the study. 

These preparations help increase the ‘signal-to-noise’ ratio and can improve the chances of detecting the physiological change to our immune defense induced by the natural product.

A surprising number of natural products trigger physiological changes almost immediately. These triggers may be through aroma or physical contact via mucosal membranes, and responses are measurable within 3 hours of consumption.  These responses may also lead to cumulative effects thus indicating both immediate and long-term benefits to our immune system.

This design tracks what happens in the body immediately after consuming a single dose of an immune supportive natural product.  It can also track more subtle priming of immune cells.  These changes are measured by taking blood samples and immediately using the immune cells for cell culture to trigger specific immune responses outside the body. This illustrates the priming/re-programming that happened to our immune defense within the body after consuming the natural product.

We have a controlled clinic environment for this type of study where the participant sits quietly in a relaxed state with minimal outside stimuli.  Blood samples for this type of study need to be processed within 2 hours, and our on-site immunology lab allows us to immediately prepare samples for culturing or flow cytometry.

In order to document such rapid changes, when the immune system itself is a moving target and undergoes day/night cycles specific to each participant. Therefore, each participant must serve as his/her own control in the study, and must consume the active nutraceutical product on one clinic visit, and consume placebo on another clinical visit. The visits must happen at the same time of the day for each participant, for the participant’s immune system to be on the same day/night phase for both visits. This allows us to conclusively attribute changes to the active product consumed by subtracting changes that happened in the same person when not consuming the active product.