The Study

Details: Moving from Approved Protocol to Planning

The excitement built into the science of an approved study eventually has to give way to the operational details grunt work.

I have been compiling possible candidates for collaborators and labs to conduct the blood/EDC/epigenetic/DNA break testing.

Designing the protocol for maximum compliance

Before those tasks can be done properly, the success of the study lies in the ability for test subjects to stick to the protocols.

As the first lab rat in this proof-of-concept study, I am highly motivated to adhere to the needed procedures.

However, I recognize that the protocols need to be designed to ensure maximum compliance by those not as deeply involved and motivated.

As a “proof of concept” study, this investigation must develop ways that will require the least amount of effort for subjects in an expanded study to comply.

Reducing the odds of unanticipated interactions

The nutritional metrics must remain rigidly the same regardless of which sources of environmental chemicals are being eliminated.

This means eating exactly the same thing, at the same occasion with the same profile … protein, carbs, fats, types of sugars, types of proteins, as well as vitamins, minerals and trace compounds.

This consistency will minimize test bias caused by nutritional changes.

In addition, exercise must remain the same from day to day.

Developing a suitable protocol and overall program is vital to both the accuracy of data as well as the ability to stick to the protocol day after day for six weeks. The two goals are not necessarily compatible.

Daily variation, but strict consistency by day of the week

This trial will require a rigid weekly regime in which every Sunday is the same, every Monday the same etc. But Sunday is different from Monday and other days of the week.

That offers a variety of meals, but simplifies the menu and preparation.

The first week following the personal baseline tests will be one of maximum EDC exposure: canned, processed frozen or processed meals pre-packaged for microwaving.

The tricky parts

The menu must be designed so that the first week of maximum plastic/processed can be easily re-created with standard and then maximum fresh foods for the rest of the trial.

All the while maintaining identical nutritional metrics.

Additionally, to eliminate any possibility of observer bias, the meals must be prepared by a third party and delivered to frozen in glass which can be microwaved.

The glass used must be hand-washed with soap containing non-EDC surfactants … and rinsed by some (as yet to be determined) protocol that assures no surfactant residues remain.

Recruiting a collaborator

Meeting these requirements demands a registered dietitian with experience in creating tailored menus for specific purposes and some experience in actually preparing menus and/or meals.

It will be desirable to find someone with advanced nutrition and biology education and skills developed in a real-life meal preparation environment.

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