CLINICAL STUDY ON EFFECT OF D-ALLULOSE (RARE SUGAR) IN SUBJECTS WITH BMI > 25
D-allulose is a pure form of rare sugar manufactured synthetically without animal or alcohol derivatives. The aim of this 24-week double-blinded, prospective, randomized controlled trial is to investigate the effect of consumption of D-allulose on overweight and obese individuals, and to compare with erythritol (non-calorie sweetener). The objectives of the trial are to evaluate and compare the effect of D-allulose and erythritol by measuring: (i) body weight and BMI change; (ii) body fat composition (iii) full blood count, HbA1c, TNF-alpha, urine, lipid, renal and liver function profiles at 12 and 24 weeks; and (iv) evaluate overall satisfaction on the D-allulose consumption and assess participants’ diet and physical activity using a novel mobile application. Healthy adults with BMI 25 and above will be recruited from the community and clinical setting. We aim to recruit a total of 80 participants of which 40 will be randomly assigned to test product (D-allulose) and 40 to control (erythritol, a non-calorie sweetener). This randomised product (test or control) is to be diluted in liquid and consumed three times a day, 30 minutes before meal or immediately after meals. Daily consumption of this randomized products will be recorded by participants via a mobile application which is also used to record meals consumed as per protocol. Baseline measurements of participants will include the following: body temperature, blood pressure, heart rate, weight and height, waist and hip circumference and percentage body fat. Baseline blood tests will include the following: full blood count, plasma insulin and glucose, HbA1c, GIP, GLP-1, TNF-alpha, fasting lipid, renal and liver function profiles and urine for microscopic examination.
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