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Because medication changes confound the interpretation of the effect of diet on glycemia, analyses were designed to account for this factor to the extent possible, as described below. Laboratory measurements were made after a h fast by technicians blind to group assignment. Hb A 1c , plasma glucose, and plasma lipids were assayed at weeks 0, 11, 22, 35, 48, 61, and All other measures were assessed at weeks 0, 22, and 74, except as noted.
Plasma glucose, cholesterol, triglyceride, and urinary albumin were measured with the use of laboratory methods previously described. At weeks 1, 11, 22, and 74, body weight, waist and hip circumference, and blood pressure were measured as previously described.
An interim analysis indicated group differences of 0. Data for the 2 cohorts were combined, such that the wk observations were collected 74 wk after baseline determinations for all participants. The primary analysis of Hb A 1c included all participants based on intention to treat.
Repeated-measures analysis of variance was performed to see whether there were effects associated with time within-person variable , diet group between-group variable , or the interaction of time and diet group. The dependent variable for the repeated-measures analysis was the Hb A 1c value at baseline and weeks 11, 22, 35, 48, 61, and Between-subjects t tests were calculated for Hb A 1c , and all other dependent measures to determine whether changes associated with the intervention diet were greater than those associated with the control diet.
Within each diet group, paired comparison t tests were calculated to test whether the change from baseline to 74 wk, or last available value, was significantly different from zero. In cases of missing Hb A 1c values, the last available values were brought forward. Because medication changes influence the dependent measures, additional analyses were done by carrying forward the last values before any medication changes for individuals whose medications for glucose or lipid control had changed, and by limiting the analysis to individuals with no medication changes.
For body weight, additional analyses were conducted with the use of baseline weights for missing values. Regression analyses assessed whether the diet group effects on Hb A 1c and body weight were significant while controlling for baseline values, and whether the diet group effect on Hb A 1c was significant while controlling for baseline Hb A 1c and changes in body weight.
Pearson's correlation coefficients were calculated for the relation between HB A 1c change and weight change. Between-group differences in diet adherence were analyzed with the use of the chi-square test. The software used was SAS for Windows, version 8. Demographic characteristics reflected those of the Washington, DC, area Table 1.
Seven vegan and 5 conventional diet participants failed to complete wk laboratory assessments. Nine vegan and 7 conventional diet participants failed to complete wk dietary records. No significant baseline clinical or demographic differences were observed between these individuals and study completers.
Selected baseline demographic and clinical characteristics of study participants 1. Both groups reduced energy intake Table 2. The decreases in total, saturated, monounsaturated, and trans fat intake and in cholesterol intake, expressed in relation to energy intake, were significantly greater in the vegan group.
Carbohydrate and fiber intakes increased in the vegan group, with smaller changes in these variables in the conventional diet group. For micronutrients, compared with the conventional diet group, the vegan group reported greater increases in vitamin C, folate, magnesium, and iron intakes and greater reductions in vitamin D, calcium, and zinc intakes. Increases in fruit and vegetable intake were greater in the vegan group. Pedometer readings and self-reported energy expenditure showed no significant between-group differences.
Nutrient, fruit, and vegetable intakes for individuals completing 74 wk of study 1. Limiting the analysis to participants who met dietary adherence criteria at 22 and 74 wk 21 vegan, 16 conventional , weight loss was 6.
The effects for time were both linear and curvilinear. The group-by-time interaction was followed with t test comparisons between groups for changes from baseline to 74 wk. In an effort to remove the confounding effect of medication changes, 2 additional analyses were conducted. Glycemia, plasma lipids, and blood pressure before medication changes 1. A regression model was constructed that included baseline Hb A 1c , weight change, and diet group as predictors of Hb A 1c change from baseline to 74 wk or last available value.
Controlling for diet group and baseline Hb A 1c values, weight change was significantly associated with Hb A 1c change; each kilogram of weight loss was associated with a 0. Reductions in total, LDL-, and non—HDL-cholesterol concentrations from baseline to 74 wk or to last available value were observed for both groups, as were reductions in triglyceride and VLDL-cholesterol concentrations in the vegan group, with no between-group differences in intention-to-treat analyses Table 3.
In analyses adjusted for medication changes, reductions in LDL and non-HDL cholesterol were significantly greater in the vegan group Table 4. No treatment-related serious adverse events were observed.
In this wk study, both diets were associated with significant weight loss. In analyses including all participants without regard to medication changes, both diets were associated with reductions in Hb A 1c ; the mean change was slightly but not significantly greater in the vegan group. In analyses controlling for medication changes, significantly greater reductions were seen in Hb A 1c values and in total and LDL-cholesterol concentrations in the vegan group.
Much of the effect of the intervention diets on glycemia appears to be mediated by weight reduction. However, the 2 diets appear to have altered energy intake by different mechanisms. Although overweight individuals in the conventional diet group were prescribed an explicit energy deficit, a low-fat vegan diet typically elicits significant weight loss in the absence of prescribed energy intake limits.
This is likely because reduced dietary fat and increased dietary fiber reduce dietary energy density ,. Individuals following self-selected plant-based diets typically have lower body weights, compared with omnivores. In a US Department of Agriculture survey of 10, adults, vegetarians and individuals on high-carbohydrate, low-fat diets had the lowest body mass indexes of the groups studied. In clinical trials, the use of plant-based diets is associated with weight reduction that is partially preserved over the long term.
In a study that used a low-fat vegan diet without added exercise in overweight postmenopausal women, median weight reduction was 4. Among individuals with cardiac disease, a lifestyle program that included a low-fat vegetarian diet and mild exercise was associated with net weight loss of A vegan diet may also be associated with reductions in intramyocellular lipid, which is strongly associated with insulin sensitivity.
The long-term effect of both diet interventions on glycemia was reduced in comparison with the short-term findings from this study. Among participants in the vegan group with no changes to diabetes medications, Hb A 1c had fallen 1. Among medication-stable participants in the conventional diet group, the Hb A 1 c reduction was 0.
Both groups retained most of their weight loss, suggesting that their diets had not returned to their baseline patterns. The principal diet change in the conventional diet group was a reduction in energy intake, which appears to be due to reduced portion sizes rather than to changes in macronutrient balance, which was close to the recommended percentages for protein, carbohydrate, and monounsaturated fat at baseline and changed only slightly during the study.
This change in energy intake was nonetheless sufficient to lead to sustained weight loss. Several studies that used conventional diets — have reported more dramatic Hb A 1c reductions 0.
The current study was approximately 1 y longer than prior studies, and during this time changes in medications are likely to occur. We have therefore taken steps to report results both with and without accounting for medication changes. Vegetarian and vegan diets are often more effective than other diets for lipid control , an important consideration, given that coronary heart disease is the main cause of mortality in diabetes.
The reduction in triglycerides associated with the vegan diet contrasts with earlier studies suggesting that diets high in refined carbohydrate may transiently increase triglyceride concentrations for some individuals ,.
It appears that high-fiber, low—glycemic index foods, such as were used in the present study, have a salutary effect on triglyceride concentrations , and the observed weight loss may also have contributed to triglyceride reductions.
The acceptability of low-fat vegetarian and vegan diets has been shown to be similar to that of other therapeutic diets in studies of individuals with cardiovascular disease 8 , young women with dysmenorrhea 9 , overweight but otherwise healthy postmenopausal women , and the current study population. Although low-fat vegan diets are generally lower in fat, saturated fat, and cholesterol and higher in fiber and complex carbohydrate, compared with omnivorous diets , , planning is important for micronutrient adequacy, particularly for sources of vitamin B, vitamin D, and calcium.
The study's strengths include its randomized design, extended duration, inclusion of individuals with long-standing diabetes, analysis of dependent measures without regard to variations in dietary adherence, statistical methods aimed at reducing the effect of medication changes, and applicability outside the research setting. The study also has weaknesses. The medication changes required for patient safety or for appropriate medical management present a challenge in outpatient diabetes studies of more than a few months' duration.
In the present study, most participants in both groups altered medications, often because of clinical success low blood glucose values , presenting a confounding variable that required special analyses. Carrying forward the last value before any medication change, as in the current study, may either under- or overestimate effects ,. Limiting the analysis to those with no medication changes reduces sample size and statistical power.
It is reassuring that all statistical models repeated-measures analysis, use of final data from all participants without regard to medication use or dietary adherence, and use of the last value before medication change led to similar conclusions, showing a mean long-term Hb A 1c —lowering effect ranging from 0.
Moreover, the persistent mean weight loss confirms the participants' reports that dietary changes were at least partially maintained. In conclusion, in individuals with type 2 diabetes participating in a research study, both a low-fat vegan diet and a diet based on ADA guidelines facilitated long-term weight reduction.
In analyses controlling for medication changes, the vegan diet appeared to be more effective for control of glycemia and plasma lipid concentrations.
Other articles in this supplement to the Journal include references —. The authors' responsibilities were as follows—NDB: participated in the study design and data analysis and drafted the manuscript; JC and DJAJ: participated in the study design and data analysis and reviewed the manuscript for critical content; GT-M: participated in recruiting, nutrition instruction, and manuscript preparation; LG: participated in nutrition instruction and reviewed the manuscript for critical content; AG: participated in nutrition instruction, conducted nutrient analyses, and reviewed the manuscript; and HF: participated in data analysis and reviewed the manuscript for critical content.
NDB is president of the Physicians Committee for Responsible Medicine and the Cancer Project, organizations that promote the use of low-fat, plant-based diets, and writes books and gives lectures about therapeutic diets, including vegan diets.
He is the author of Dr. Neal Barnard's Program for Reversing Diabetes and receives royalties from its sales. None of the other authors had any personal or financial conflict of interest.
Toggle navigation. Fruit-based savory snacks were not included. White potatoes, fried potatoes, and vegetable-based savory snacks were not included. Type 2 diabetes and the vegetarian diet.
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Offering new hope to millions, this new nutritional approach to diabetes will dramatically alter the way we think about treating the disease Until now, most health professionals have considered diabetes a one-way street. Once you developed it, you were stuck with it—and you could anticipate one complication after another, from worsening eyesight and nerve symptoms to heart To ask other readers questions aboutDr.
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