PALEOLITHIC VS Healthy ADA DIETS FOR TREATMENT OF POLYCYSTIC OVARIAN SYNDROME (PCOS)

Experimental Design and Methods This is a prospective, open labeled, randomized diet intervention study done on adult participants with PCOS. After signing informed consents, participants will be asked to eat a recommended ADA diet for two weeks (run in period). Participants will then have baseline testing, including: urine and blood tests to evaluate insulin resistance (fasting glucose and insulin, 2 hour oral glucose tolerance test), electrolytes to assess acid-base status, ovarian volume and testosterone levels measured to assess severity of PCOS, and questionnaires about menstrual frequency, eating habits and stress. Participants will then be randomized to either a high fruits and vegetable Paleo Diet for 4-8 months or a standard ADA-recommended diet for the first 4 months followed by Paleo Diet for 0-4 months.All participants will have the option of limiting their participation to just 4 months or extending participation to the full 8 months depending on their ongoing level of interest. All testing will be repeated at 4 months (crossover point) and at completion of the diets at 8 months. The primary outcome variables are menstrual cycle frequency and ovarian volume, and secondary outcomes include metabolic profiles and eating/behavior questionnaires

Procedures

1. Diet: All participants will initially be given diet information on ADA diet for the "Run In" period , including printed ADA diet instructions and advice on caloric intake. The ADA diet includes foods that are excluded in the Paleo Diet, such as grains, legumes and dairy products and will also contain less potassium. All participants will be instructed not to add salt to their food when cooking or eating. At 2 weeks, participants will be randomized to Paleo Diet arm or ADA diet arm. Participants on the Paleo Diet arm will require a "ramp-up" phase for one week (start out with 1 Paleo meal per day, then two, and then all meals will be on a Paleolithic-type menu, which contains approximately an average of 142 grams of protein and 12,200 mg of potassium per 3000 kcal. Participants on the ADA diet arm will continue on the run-in diet.

After 16 weeks, the participants in the ADA arm will be changed over to the Paleo arm if they wish to continue participation. They will also require a "ramp-up" phase for 1 week. In our previous studies, we have seen a crossover effect at one month going from the Paleo to the ADA diet, but not from the ADA to the Paleo arm.

We will give all participants pertinent websites and written information about their specific diet, as well as sample menus. We will give participants in the Paleo arm a list of foods to avoid (e.g., dairy, grains, legumes, processed foods).