Does your product work quickly?

Most natural products have a very quick effect upon consumption of a single dose.  Some are readily noticeable by most people - think coffee.  

For things that help the immune system, stem cells, etc., the trick is to design methods to document beneficial efficacy within 1 - 3 hours of consumption.

The basics of what we now call the Quiet Study design were developed 30 years ago out of a frustration of not being able to capture measurable objective results on a natural product that clearly had long term health benefits.

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. 

• Each participant must serve as his/her own control in the study, they 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.

 The Quiet Study design controls for the effects on our body’s normal day/night cycle (the circadian rhythm) that affects immune cells, stem cells, and many metabolic functions.    

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.

The Quiet Study design is indeed “Quiet”.  The clinic and rooms must be calm and quiet. Adrenalin surges will inhibit the changes we are looking for.  Acute stress inhibits the cellular behavior involved in immune and stem cell surveillance – this has been described as the ‘Stress response’.  

Before a person can participate in a Quiet Study, they must be familiar with the procedures, clinic, and staff.  To further reduce stress during clinic visits, they must also have good veins to reduce stress during and between blood draws. 

The clinic is managed to eliminate unnecessary sensory input, such as smells of food and the sounds of phones ringing.  Participants are not allowed to use phones or internet during visits. They are instructed to remain calm and slightly bored, and engaging in activities like peaceful reading, knitting, Sudoku or crosswords.  

 Clinical trials are designed to establish a scientific foundation to support marketing claims.  The Quiet Study design accommodates a modular design, where the initial module explores several desired directions for marketing claims.  This module may include several doses of an active test product.  The module may include few participants. 

A second module is planned based on the results of the initial module, pursuing further substantiation of the claims that showed the most robust results on the initial module. 

Acute effects = rapid change. Claims are health-related, not disease-related: ‘Works in 2 hours’. ‘Rapid immune modulation’. ‘Increased numbers of natural killer cells over 3 hours’. ‘Heightened immune surveillance’. 

A natural product that works – typically works fast.  However, this is more like a gentle whisper than a trumpet fanfare.  We need a Quiet Study design to detect the change. 

The changes induced after consuming a single dose of an efficacious natural product show orchestrated waves of changes, comparable to a gentle symphony.  There are many players creating a purposeful and harmonious melody.  

In our body, it starts at the gut/immune interface in the gut mucosa.  The cells lining the gut sense the product and communicate to immune cells immediately inside the gut lining.  This triggers a nerve signal to the brain, and the brain orchestrates the symphony throughout the body. The exact tune varies between different natural products. 

Typically, immune cells responsible for immediate action are affected, and are encouraged to increase their surveillance in the body, looking for invading bacteria and viruses.  Cytokine levels in the blood also show waves of change, with initial, often transient, signals to encourage immune surveillance, followed by waves of cellular trafficking.