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IRCT2015050912571N2 IRCT 2016-09-15 Vice chancellor for research, Shahid Sadoughi University of Mecical Sciences The safety and effect of a new sweetener (Lacritose) compared to sugar and glucose on postprandial blood sugar The effects of a newly designed natural sweetener (Lacritose) compared to sucrose and glucose on blood glucose concentrations and possible gastrointestinal reactions in patients with type 2 diabetes: a double-blind randomized three way cross-over clinical trial 2016-02-20 anticipated 20 Complete https://irct.ir/trial/12619 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: Randomization: All Participants will randomly ingest the three intervention beverages [consisting of 50 gram of test sugars (lacritose, sucrose and glucose) and tap water] coded as A, B or C, for one time. The order of ingesting the test beverages (rolling methods) will be randomized by computer using statistical package for social sciences (SPSS) software version 15. Participants will be randomized into 6 rolling methods (ABC, ACB, BCA, BAC, CAB, and CBA). The random order will be written on a paper and will be kept in opaque envelopes and after presence of subjects in laboratory, the pocket will be opened and the order of ingesting beverages will be revealed for the study team. 2-3 Non-insulin-dependent diabetes mellitus. Intervention 1: 50 grams of Lacritose dissolved in 300 ml of tap water. Intervention 2: 50 grams of sucrose dissolved in 300 ml of tap water. Intervention 3: 50 grams of glucose dissolved in 300 ml of tap water.
public Dr. Amirhoushang Mehrparvar
Vice-chancellary for research and technology, Shahid Sadoughi University of Medical Sciences, bahonar Square, Yazd, Iran
Yazd Iran (Islamic Republic of) +98 35 3726 6711 ah.mehrparvar@gmail.com Shahid Sadoughi University of Medical Sciences scientific Dr. Amin Salehi-Abargouei
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Yazd Iran (Islamic Republic of) +98 35 3820 9100 abargouei@gmail.com; abargouei@hlth.mui.ac.ir Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, I Iran (Islamic Republic of) Inclusion criteria: Type 2 diabetic patients (n=20) with fasting blood sugar >125 mg/dl and lower than 200 mg/dl, aged 20 to 60. Exclusion criteria: Participants will not be included in the trial if they were pregnant or lactating, had severe infection, endocrine disorders or acute diseases at the enrollment. Participants who intend to exit with any reasons or show any adverse reaction to test sugars will also be excluded from the study. . 20 years 60 years Both E11 non insulin dependent diabetes mellitus Treatment - Drugs Placebo Placebo 50 grams of Lacritose dissolved in 300 ml of tap water 50 grams of sucrose dissolved in 300 ml of tap water 50 grams of glucose dissolved in 300 ml of tap water Postprandial blood sugar. Timepoint: Every 30 minutes up to 2 hours after ingesting the test beverages. Method of measurement: Using pars azmoon kits using automated azalyzer. Gastrointestinal symptoms. Timepoint: 24 hour after ingesting the test beverages. Method of measurement: Gastrointestinal symptoms questionnaire. Vice chancellor for research, Shahid Sadoughi University of Mecical Sciences Approved 2015-07-01 Ethics committe of Shahid Sadoughi University of Medical Sciences Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran Yazd Iran (Islamic Republic of)