ABSTRACT
AIMS: Co-management of weight and glycaemia is critical yet challenging in type 1 diabetes (T1D). We evaluated the effect of a hypocaloric low carbohydrate, hypocaloric moderate low fat, and Mediterranean diet without calorie restriction on weight and glycaemia in young adults with T1D and overweight or obesity. MATERIALS AND METHODS: We implemented a 9-month Sequential, Multiple Assignment, Randomized Trial pilot among adults aged 19-30 years with T1D for ≥1 year and body mass index 27-39.9 kg/m2 . Re-randomization occurred at 3 and 6 months if the assigned diet was not acceptable or not effective. We report results from the initial 3-month diet period and re-randomization statistics before shutdowns due to COVID-19 for primary [weight, haemoglobin A1c (HbA1c), percentage of time below range <70 mg/dl] and secondary outcomes [body fat percentage, percentage of time in range (70-180 mg/dl), and percentage of time below range <54 mg/dl]. Models adjusted for design, demographic and clinical covariates tested changes in outcomes and diet differences. RESULTS: Adjusted weight and HbA1c (n = 38) changed by -2.7 kg (95% CI -3.8, -1.5, P < .0001) and -0.91 percentage points (95% CI -1.5, -0.30, P = .005), respectively, while adjusted body fat percentage remained stable, on average (P = .21). Hypoglycaemia indices remained unchanged following adjustment (n = 28, P > .05). Variability in all outcomes, including weight change, was considerable (57.9% were re-randomized primarily due to loss of <2% body weight). No outcomes varied by diet. CONCLUSIONS: Three months of a diet, irrespective of macronutrient distribution or caloric restriction, resulted in weight loss while improving or maintaining HbA1c levels without increasing hypoglycaemia in adults with T1D.
ABSTRACT
BACKGROUND: Investigate the effectiveness of the scientific 4 Phases Method, a methodology developed by EMAGRECENTRO, which is based on a ketogenic approach (total carbohydrate intake <40 g/day; including fibers) associated with health coach assistance, in promoting reductions in body weight, body mass index (BMI), and waist circumference after 5 weeks of methodology application. METHODS: Record files from 354 individuals, both sexes, aged between 18 and 67, who took part in the 4 Phases Method were used to develop this study. Age, sex, weight, height, BMI, waist circumference measurement, and the presence of ketone bodies in the urine were evaluated before (baseline) and after 5 weeks of the 4 Phases application. RESULTS: In general, a significant reduction in body weight (-7.8 ± 1.2 kg, p < 0.0001), BMI (-2.8 ± 0.4 kg/m2, p < 0.0001), and waist circumference measurement (-7.6 ± 0.4 cm, p < 0.0001) was found after the application of the 4 Phases Method, regardless of age, gender, and BMI. CONCLUSIONS: Taken together, our results demonstrated that the 4 Phases Method was able to promote significant body weight, BMI, and waist circumference reductions in the short term, particularly by associating a ketogenic intake strategy with a regular close follow-up weekly consultation with a health coach assistance.