Volunteers were then ranked in order of A1c concentrations. Participants were asked to describe themselves as white black American Indian, Eskimo, Aleut or Asian, Pacific Islander and describe their ethnicity as either Hispanic or non-Hispanic.Īfter medical history and physical examination, A1c was assayed using affinity chromatography on an Abbott IMx analyzer (Abbott Diagnostics, Abbott Park, IL) ( 6). Definition of race/ethnicity was required by the National Institutes of Health to ascertain balance in group assignments and assess the degree to which the participant sample reflected the community from which it was drawn. Exclusionary criteria included hemoglobin A1c (A1c) values 10.5%, use of insulin for >5 years, tobacco use within the preceding 6 months, consumption of more than 2 alcoholic beverages per day, current drug abuse, pregnancy, unstable medical status, and current use of a low-fat, vegetarian diet (use of other therapeutic diets at baseline did not preclude participation). Briefly, individuals with type 2 diabetes, defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician’s diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months, were recruited through newspaper advertisements in the Washington, D.C., area in 2 cohorts (October – December 2004 and October– December 2005), to complete the 74-week study from January 2004 through June 2005, and January 2005 through June 2006, respectively. The overall study methods have been previously described ( 4). The present investigation tests the hypothesis that a low-fat vegan diet has an acceptability comparable to or better than that of a more conventional diabetes diet. The results of that assessment, using global measures, including attrition and adherence rates and reported changes in dietary intake, as well as specific measures of dietary behavior, diet acceptability, diet-related benefits and symptoms, and food cravings, are reported herein. Therefore, in the course of this trial, the acceptability of the low-fat vegan diet and the control diet was quantified over both the short (22 weeks) and long (74 weeks) term. Among medication-stable participants, A1c fell 1.23 points over 22 weeks in the vegan group, compared to 0.38 points in the ADA group (P = 0.01) body weight fell 6.5 kg in the vegan group and 3.1 kg in the ADA group (P < 0.001) and LDL-cholesterol fell 21.2% in the vegan group and 10.7% in the ADA group (P = 0.02).ĭietary adherence depends on the acceptability of prescribed diets. A control group followed 2003 American Diabetes Association (ADA) guidelines. Based on prior studies suggesting that low-fat, plant-based diets reduce the risk of diabetes and may facilitate its management ( 5), the study design used a low-fat vegan diet and did not require carbohydrate counting, exchange lists, or portion limits ( 4). However, some researchers and clinicians have raised concerns about affected individuals’ ability to understand and adhere to prescribed diets ( 2, 3).Ī recent randomized, controlled trial in individuals with type 2 diabetes tested a diet regimen relying on qualitative, rather than quantitative changes ( 4). Medical nutrition therapy is integral to diabetes management ( 1). The most urgent clinical question regarding therapeutic diets is not whether they work, but whether they are sustainable.
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