Patients should receive nutritional intervention in the form of counseling and be assigned to one of two groups:
- The control group should receive counseling based on the consensus view on optimal nutrition. As the "gold standard" with regards to nutrition seem to be the advise from the U.S. Department of Agriculture(!) (USDA), from the American Heart Association (AHA) and from the American Diabetes Association (ADA), the control group should receive counseling based on their advise.
- The treatment group ("Paleo") should receive counseling based on the avoidance of foods containing evolutionary novel ingredients (more or less an "Elimination Diet" based on evolutionary plausibilty):
1. Avoidance of cereal grains and soy
2. Avoidance of dairy
3. Avoidance of seed oils
Pre-intervention levels of those four ingredients should be recorded. Calorie-countring should not be recommended, macro-nutritient ratios should not be prescribed, the diet should neither be low-carb, nor low-fat, nor low-meat – so the health effects of these four evolutionary novel food ingredients can be investigated. However, some minimum recommendations of what foods to primarily eat should be made.
- Obesity (doh!)
- Type 2 Diabetes
- Acne*, Dermatitis, Psoriasis, etc.
- Allergies (Hay Fever and the like)
- Cardiovascular Diseases
- Other neurological/psychological/mental/etc. health problems (e.g. Bipolar Disorder)
- Multiple Sclerosis (MS), cf. Terry Wahls
The dietary advise should be followed for 3 months, possibly with an extension to 6 and 12 months.
Objective markers for each disease (e.g. weight for obesity) should be recorded as the primary disease makers by the investigators before the study, at 1 month, and after that at each 3-month-point. Surrogate markers should be recorded in addition, but not for the primary measurement of outcomes.
Patients should have a simple food and symptom diary. If possible, the patient should be encouraged to record disease makers, both objective (e.g. daily activity level with an odometer, daily weight) and subjective (e.g. perceived fatigue).
After a patient stops a diet (either at the end of study, or patient drops out), she/he should be (if possible) followed for another month with regards the aforementioned disease markers and symptoms.
If positive health effects from an Paleo Diet are found for one disease, follow-up studies could be further refined with an focus on individual components (e.g. only dairy, or dairy from pasteurized* milk).
There is a lot do and many pitfalls to avoid before such studies would get off the ground…
* As I traced my acne back to dairy from pasteurized milk (and to a lesser extent to eggs), studies finding an positive effect of avoidance of dairy could further look into the difference between raw-milk dairy and pasteurized-milk dairy.