Efficacy of D-allulose on Weight and Fat Loss and Insulin Resistance in Non-diabetic Obese Subjects

Subjects and methods Study product The test product is the pure D-allulose which is a rare sugar. The control product is the non-calorie sweetener erythritol. Study design This is a single center, prospective, randomized, control trial. After informed consent is obtained, history taking and physical examination will be performed to ensure that the patients met all inclusion criteria and had no exclusion criteria. At the screening day, venous blood samples will be collected following an overnight fasting of at least 8 hours. Complete blood count (CBC), chemistry including fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), insulin, blood urea nitrogen (BUN), creatinine, lipid profiles (total cholesterol, HDL-C, LDL-C, triglyceride, very low-density lipoprotein), blood urea nitrogen, creatinine, total protein, Albumin, albumin/globulin ratio, glutamine oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT) , Gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), total bilirubin (including Direct and Indirect), alkaline phosphatase, uric acid, plasma amylase, cholinesterase, Sodium, Chloride, potassium, carbon dioxide , Calcium, inorganic phosphate, magnesium, plasma iron will be measured. Urine will be collected for urinalysis and urine pregnancy test will be performed to exclude pregnant women from the study. Visceral fat area (VFA), subcutaneous fat area (SFA), total fat area (TFA) will be measured with abdominal CT scan at umbilical level (L4) and bioelectrical impedance at D-7 or screening visit. The eligible subjects will be randomized with an equal probability of receiving either pure D-allulose 5 g 3 times a day from 30 min before meal to right after meals (with any liquid) plus conventional therapy or placebo (non-calorie sweetener erythritol) 5 g 3 times a day from 30 min before meal to right after meal (with any liquid) plus conventional therapy for 24 weeks. Both the subjects and the investigator will be blinded to the type of the product. Subjects in both groups will be instructed to modify their lifestyle to control their diet to 1200 kcal for women and 1500 kcal for men and increase physical activity. Subjects will be asked to do 3-d food record per week (2 working days and 1 weekend) entire of the study. Subjects will need to record any exercise they do including type and duration during in the study. Subjects will be asked to visit every 4 weeks for follow-up for totally 9 visits including screening day or D -7, D0, end of week 4, 8, 12, 16, 20, 24 and 4 weeks post intervention (at the end of week 28) in 29 weeks duration. Assessment of insulin resistance index (IRI) was calculated from the homeostasis model assessment of insulin resistance (HOMA-IR) using FPG (mmol/L) multiply by fasting insulin (U/ml) divided with 22.5. The satisfaction of the product will be asked at 4 weeks, 12 weeks and 24 weeks after consumption of the study products. From the visit 1 to visit 8, same blood samples as the screening will be measured. At the screening visit, visit 4 and visit 7, CT abdomen measurements will be conducted. At the visit 1 and visit 7, adiponectin, leptin, tumor necrosis factor -alpha will be measured. At the visit 1, visit 4, visit 7 and visit 8, other lipid profiles will be measured including very low-density lipoprotein and Chylomicron fractionation , Apolipoprotein (AI, AII，C-III, E), Apolipoprotein (B48, B100), nonesterified fatty acid Adverse Event Assessment At each visit, subjects will be asked an open question as if he/she has experienced any abnormal symptoms. Any symptom reported by the subject will be recorded as an adverse events with details of the event, its severity, start and stop dates, and relationship to study products. Withdrawal criteria 1. Consume study product less than 90% during treatment period 2. Start taking any medication that may affect body weight during in the study.