13TSB_N4L2CRD: CELLDEX-Developement of a low calorie bulk sugar replacer

研究1-纤维糊精的耐受性这主要是一项描述性研究，以表征在食物基质中消耗的单一递增剂量(10g、20g、30g、50g)纤维糊精的耐受性。将招募6名健康、非肥胖的男性和6名女性志愿者(年龄18-40岁，体重指数18-30 kg/m2)，以评估针对不良胃肠道症状的耐受阈值。方案摘要；体检访问。4次研究访问含纤维糊精10、20、30或50克的食物的摄入量(分别为研究访问1-4次)间隔至少一周完成食欲和肠道症状的视觉模拟量表摄取后9小时的饮食和肠道症状日记在每次访问的前一天和之后的48小时研究2-纤维糊精的消化和发酵除了人工肠道研究外，计划在16名健康的非肥胖志愿者(男性/女性，18-40岁，BMI 18-30 kg/m2)中进行一项体内研究，以评估纤维糊精的消化和发酵与蔗糖和多聚葡萄糖的比较。纤维糊精的剂量将从耐受性研究(研究1)中确定。将采集呼气样本进行氢气评估，并采集动脉化静脉血进行葡萄糖和胰岛素分析。3次研究访问随机、交叉、双盲研究设计含纤维糊精、多聚葡萄糖或蔗糖(碳水化合物含量匹配)的食物摄入量收集呼吸和血样5小时后完成食欲和肠道症状的视觉模拟量表每次访问后48小时记录饮食和肠道症状日记研究3-纤维糊精和食欲本研究将测试作为早餐零食食用的纤维糊精对16名健康非肥胖男性志愿者(年龄18-40岁，BMI 18-30 kg/m2)主观食欲、下一餐能量摄入和胰岛素激素的影响。纤维糊精的剂量将从耐受性研究(研究1)中确定。将含有纤维糊精的食品与含有可消化(蔗糖)和不可消化(多聚葡萄糖)碳水化合物(碳水化合物含量相匹配)的食品进行比较。否则，产品在每个场合都是相同的，蛋白质/脂肪/碳水化合物的含量反映了正常的零食，能量含量为200-250千卡。然后每天食用一次，持续两周，在第1天和第14天的临时午餐中评估对能量摄入的影响。在每个补充期的第二周也将记录食物日记，并在每2周周期前后测量体重。方案摘要；体检访问。6次研究访问(补充期前和补充期2周后)3次补充期，在随机、交叉、双盲研究之间进行2周“清洗”设计摄入含有纤维糊精、多聚葡萄糖或蔗糖(碳水化合物含量匹配)的食品对产品的急性和急性慢性反应完成食欲和肠道症状的视觉模拟量表在每次访问后4小时饮食和肠道症状日记在每次访问后48小时内在每个干预期的第二周内保持三天的饮食日记

Study 1 - Tolerability of cellodextrins This is primarily a descriptive study to characterise the tolerability of single, ascending doses (10g, 20g, 30g, 50g) of cellodextrin, consumed in a food matrix. Six healthy, non-obese male and 6 female volunteers (age 18-40yrs, BMI 18-30kg/m2) would be recruited to allow estimation of a tolerance threshold with respect to adverse GI symptoms. Protocol Summary; Medical screening visit. 4x Study visits Consumption of food product containing 10, 20, 30 or 50g of cellodextrin (on study visits 1-4 respectively)Visits to be separated by at least a weekCompletion of visual analogue scales for appetite and bowel symptoms for 9hrs after consumption Diet and bowel symptom diary kept on the day before and for 48hrs after each visitStudy 2 - Digestion and fermentation of cellodextrinsIn addition to artificial gut studies, it is proposed to conduct an in vivo study assessing digestion and fermentation of cellodextrin in comparison with sucrose and polydextrose in 16 healthy, non-obese volunteers (M/F, age 18-40yrs, BMI 18-30kg/m2). Dose of cellodextrin would be determined from the tolerability study (Study 1). Breath samples will be collected for hydrogen assessment, and arterialised venous blood will be collected for glucose and insulin analysis.Protocol Summary; Medical screening visit. 3x Study visits Randomised, cross-over, double-blinded study designConsumption of food product containing cellodextrin, polydextrose or sucrose (carbohydrate content matched)Collection of breath and blood samplesCompletion of visual analogue scales for appetite and bowel symptoms for 5hrs after consumption Diet and bowel symptom diary kept for 48hrs after each visitStudy 3 - Cellodextrins and appetiteThis study would test the effect of cellodextrin, consumed as a midmorning snack, on subjective appetite, subsequent energy intake at the next meal and incretin hormones, in 16 healthy non-obese male volunteers (age 18-40yrs, BMI 18-30kg/m2). Dose of cellodextrin would be determined from the tolerability study (Study 1). A food product containing cellodextrin would be compared with ones containing digestible (sucrose) and indigestible (polydextrose) carbohydrate (matched carbohydrate content). The product would otherwise be the same on each occasion with a protein /fat/carbohydrate content reflecting a normal snack and an energy content of 200-250 kcal. This product would then be consumed once a day for 2 weeks, with the impact on energy intake at an ad-libitum lunch assessed on day 1 and day 14. Food diaries would also be kept during the 2nd week of each supplementation period and body weight measured before and after each 2wk period.Protocol Summary;Medical screening visit. 6x Study visits (pre- and post a 2wk supplementation period) 3x supplementation periods with a 2wk 'wash-out' in between Randomised, cross-over, double-blinded study designConsumption of food product containing cellodextrin, polydextrose or sucrose(carbohydrate content matched)Acute and acute-on-chronic response to the productsCompletion of visual analogue scales for appetite and bowel symptoms for 4hrs after consumption Diet and bowel symptom diary kept for 48hrs after each visitThree-day diet diary kept during week 2 of each intervention period