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Abstract
Consensus has not been reached on what constitutes an optimal diet in individuals with prediabetes and type 2 diabetes (T2DM), especially between low-carbohydrate options.To compare two low-carbohydrate diets with 3 key similarities (incorporate non-starchy vegetables and avoid added sugars and refined grains) and 3 key differences (incorporate vs avoid legumes, fruits, and whole intact grains), for their effects on glucose control and cardiometabolic risk factors in individuals with prediabetes and T2DM.Keto-Med was a randomized, crossover, interventional trial. Forty participants aged = 18 years with prediabetes or T2DM followed a Well Formulated Ketogenic Diet (WFKD) and Mediterranean-Plus diet (Med-Plus) for 12-weeks each, in random order. Diets shared 3 key similarities noted above. Med-Plus incorporated legumes, fruits, and whole intact grains while WFKD avoided them. Primary outcome was % change in HbA1c after 12-weeks on each diet. Secondary and exploratory outcomes included % change in body weight, fasting insulin, glucose, and blood lipids, glucose (continuous glucose monitor), and nutrient intake.Primary analysis had n = 33 with complete data. HbA1c did not differ between diets at 12-weeks. Triglycerides decreased more for WFKD (% change(SEM)): -16%(4%) vs -5%(6%), p = 0.02) and LDL-C was higher for WFKD (+10%(4%) vs -5%(5%), p = 0.01). Weight decreased 8%(1%) vs 7%(1%) and HDL-C increased 11%(2%) vs 7%(3%) for WFKD vs Med-Plus, respectively; however, there was a significant interaction of diet by order for both. Participants had lower intakes of fiber and 3 nutrients on WFKD vs Med-Plus. Twelve-week follow-up data suggested Med-Plus diet was more sustainable.HbA1c was not different between diet phases after 12-weeks, but improved from baseline on both diets, likely due to several shared dietary aspects. WFKD was beneficial for greater decrease in triglycerides, but also had potential untoward risks from elevated LDL-C, and lower nutrient intakes from avoiding legumes, fruits, and whole intact grains, as well as being less sustainable.clinicaltrials.gov NCT03810378.
View details for DOI 10.1093/ajcn/nqac154
View details for PubMedID 35641199