Currently Diabetes affects over 500 million people, worldwide, and the expense of treating this disease exceeded $870 Billion US dollars. Diabetes Mellitus Type 2 (DM2) is comorbid with numerous other pathologies including obesity and hypertension. The objective of this 6-month controlled pilot study was to determine if food allergy elimination is effective in reducing the HbA1c values in Pre-diabetic (PDM) patents.
Methods: Twenty-four PDM subjects were enrolled in this study (5.7 - 6.4 HbA1c), obesity and hypertension were also seen in these subjects (N=24). All subjects received nutritional counseling and recommendations for aerobic exercise, (the current standard of care for PDM). The EXP subjects had blood drawn for ALCAT leukocyte reaction testing to identify sub-acute food allergens (N=250 foods). Food Allergens were eliminated (or exchanged) for the 6-month study’s duration. The dependent variables in this study will be change in HbA1c and BMI (Enrolment, 3 and 6 months). Differences were calculated using a repeated measures ANOVA.
Results: The preliminary results at 90 of 180 days revealed that the EXP subjects had a significant HbA1c reduction (mean -0.8), while the CON subjects showed increases in A1c (mean +0.7), (p < 0.0001). The EXP subjects also showed significant reductions in BMI (-1.1), Blood pressure (-20%). Fat Mass (-8 pounds), and waist circumference (-2”).
Conclusion: The purpose of this controlled 6-month pilot study was to determine if food allergy elimination is effective in reducing the HbA1c values in Pre-diabetic (PDM) patents, and that change was significant in the first 90 days. The next investigation will examine efficacy of this protocol in a 4-year, global, randomized controlled trial.
F. Willis: None. B. Flint: None.
Travel will be paid for by Cell Science Systems.
