Subjects were randomly assigned to the InsP6-diet group or to the non-InsP6-diet group for 12 weeks.
T2DM
HYPOGLYCEMIA, BLOOD
After 12 weeks, each group was given a 12-week washout period, and then switched to the alternate diet for 12 weeks. All patients were then followed for an additional 12 weeks. Patients received an InsP6 diet (diet plan with InsP6 supplementation) or a non-InsP6 diet (the same diet plan without InsP6 supplementation). Blood test, urine samples, food frequency questionnaire, clinical histories, and physical and anthropometric measurements were prospectively collected during the trial.The InsP6 supplementation group consumed one pill of 380 mg calcium-magnesium InsP6 (Broken Laboratorios, SALVAT S.A.) with meals three times each day. Both groups followed a five-meal-a-day diet that comprised fruits, vegetables, fish, shellfish, meat, eggs, olive oil, and low-fat dairy items. This diet was created in Spain to give the appropriate quantities of calories, macronutrients, fiber, minerals, and vitamins for patients with T2DM. Patients were especially counseled not to consume foods high in InsP6 (cereals, legumes, nuts), but instead to substitute white bread, white rice (not basmati), pasta, white flour, potatoes, and non-whole wheat semolina. A trained dietician provided oral and written information on their food plans to all patients, as well as assistance and monthly check-ins. Patients were strongly asked to strictly adhere to the offered instructions and to report any changes in their food consumption (i.e., any deviations from the allotted diet). The dietician assessed supplementation (pills were counted to ensure a minimum of 80% supplement use) and dietary compliance at each appointment.Inclusion criteria included: (i) being 18 years or older; (ii) having stable glycemic control with no medication modifications in the past 3 months; and (iv) having a low food intake of InsP6 (as determined by dietary questionnaires). During the experiment, participants were told not to alter their anti-hyperglycemic medicine (dose or/and drug) or daily insulin demand by more than 10% unless they encountered a moderate glycemic excursion (fasting capillary glucose levels equal to or more than 250 mg/mL) for 2 consecutive days or category III hypoglycemia.With 80% power and a 95% confidence interval, the minimal number of patients required to detect a 20% difference in adiponectin levels at the conclusion of the trial was 30 patients per group.An impartial researcher with no clinical participation in the experiment produced the randomization sequence using Excel software (Microsoft Office 2010) and stratified it with a 1:1 allocation using a random block of four.An impartial researcher oversaw the allocation consignment recruiting process, enrolling and evaluating individuals in a sequential sequence. There was no blinding after the randomization procedure for either the patients who participated in the trial or the researchers who delivered the various regimens. There was, however, blinding for researchers analyzing results until the end of the trial.