A clinical trial was conducted by Dr. Pouya Shafipour, MD (Bariatric medicine and family practice, Board Certified, award winning research specialist; see BIO) as Primary care Physician in West Los Angeles, CA. The clinical trial was conducted with Patients implementing TRANSFORMATIONS’ diet & treatment programs over a period of 10 weeks during 2010 & 2011.

Purpose of Clinical Trial: A study & clinical trial to determine the effectiveness of a hypoglycemic ketotic diet offered by a primary care physician on various markers associated with pre-diabetic, overweight and obesity.  This diet provides 40-50 grams of Carbohydrates, and 60-70 grams of Lean protein to pre-diabetic, overweight and obese patients that had one or more co-morbidity associated with being pre-diabetic, overweight and obesity.  After being on the diet for at least 10 weeks various makers were measured and put into a statistical chart showing average actual & percentage marker analysis. (See Clinical Analysis Charts) These markers include: weight loss, BMI loss, fat loss, as well as changes in cholesterol, blood pressure, blood sugar, triglycerides and inches lost across 7 point body measurements (Neck, arms, forearms, Chest, waist, hip, and thighs).

Selection criteria, Methods, and Protocols: Patients were selected based on their Body Mass Index (BMI) as well as one or more co-morbidity associated with pre-diabetes, overweight or obesity.  Patients’ had to have a minimum BMI of above 25 and one or more co-morbidity associated with overweight or obesity.  These can include hyperglycemia, diabetes, hypertension, hyperlipidemia, sleep apnea, and metabolic syndrome.  These patients were either primary patients of Dr. Shafipour or were referred by primary care physician to join the program to improve their medical condition and lose weight.  Before joining the program all the patients had a physical exam, an EKG and basic labs like comprehensive metabolic panel, fasting lipid panel, and TSH.  Afterwards, they were given a quick introduction into the program and what it entailed; upon agreement, they signed an informed consent and enrolled into the program.

Males were put on a hypoglycemic ketotic diet that provided them with 25 grams of Carbohydrates (from selected fruits and vegetables), and 70 grams of Lean Protein.  Fat values were not factored in the diet but all the consumed fat in the meal was supposed to be lean and low in saturated fat (non-fat foods were not recommended due to high starch content). All the patients also consumed 4 snacks in the form of nutritional supplements added to water (provided by TRANSFORMATIONS), which provided them with a total of 27 grams of carbohydrates and 12 grams of protein.  This increased their total carbohydrates to 52 grams and protein to 82 grams of protein per day.
 
Females were put on a diet, which included 20 grams of Carbohydrates (selected fruits and vegetables) and 50 grams of lean Protein.  They also consumed four nutritional supplements mentioned above to total their daily carbohydrate intake to 47 grams and Protein to 62 grams. 

All the patients were provided with a easy to follow kit & book (published by the company TRANSFORMATIONS) which included the diet details as well as a food scale to measure their food and ketone sticks to measure the ketones in their urine and ensure they were in mild ketosis by the first week of being on the diet.   Patients were then consulted and followed on a weekly or biweekly basis based on their availability. During the follow up visits, their weight and 7 points of their body (neck, arms, forearms, chest, waist, hip, and thighs diameters) were measured.  Patients also had their body fat measured using a bio-impedance device.  Patients were on a minimum of 5 weeks of weight loss and 5 weeks of maintenance.  During the maintenance phase, the foods that were restricted were gradually re-introduced back into their diet. This 5-week period provided an opportunity for the patients to detect food allergies such as potential wheat or other starch allergies and nutritional deficiencies; they also learned how to maintain their weight and blood sugar in the normal range despite eating a non-restrictive diet.

Results: Patients enrolled and completed at least 10 weeks or more of the program showed average results as the following:

1. Weight Loss: an average 27.3 Lbs. or 12.2% weight loss
2. BMI: an average 4.79 points or 10.6% BMI loss
3. Inches: an average 18.65 inches lost (7 point body measurements)
4. Body Fat: an average 6.41% reduction in body fat percentage and total overall decrease of 13.5% per patient
5. Cholesterol: an average 48.91 points or 20.4% reduction in total cholesterol; an average 31.2 points or 17.5% average reduction in LDL; an average increase of 8.67 points or 20.6% average increase in HDL
6. Blood Pressure: an average 20.2 points or 13.5% reduction in systolic blood pressure; an average 10.1 points or 9.9% reduction in diastolic blood pressure
7. Triglycerides: an average 86 points or 40% reduction in triglyceride levels
8. Blood Sugar: an average 41.7 points or 19.4% reduction in fasting blood sugar.

Conclusions Reached: the effectiveness of a hypoglycemic ketotic diet offered by a primary care physician on various markers associated with pre-diabetic, overweight and obesity Patients was conclusive and positive; as remarkable results were achieved by the patients in the clinical trial.  The TRANSFORMATIONS program & three balanced meals consisting of 40-50 grams of Carbohydrates of the list of approved foods, and 60-70 grams of Lean protein to pre-diabetic, overweight and obese patients coupled with the 4 daily snacks provided a lifestyle change that normalized all markers, identified unhealthy markers for further treatment programs as required. The program provided increased energy, education of food choices and empowerment for Patients maintain their blood sugar levels to never become diabetic. Note: follow up marker testing of patients 6 to 18 months later showed little to no weight gain and in some patients continued loss of weight and inches was recorded.

Patient Privacy: All the patients that entered the study signed an informed consent about a hypoglycemic ketotic diet. They all acknowledged their enrollment into a specific medically supervised pre-diabetic & weight loss program. In the presentation of the study, clinical trial and results, only patients' trial #, sex, age and medical condition was revealed. Name, medical records, digital photographs or any other identifying information was kept confidential and patient privacy was honored. Stock photos were used to protect the identity of actual clinical patients.