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

研究1 -纤维素糊精的耐受性这主要是一项描述性研究，以表征单次递增剂量（10g, 20g, 30g, 50g）纤维素糊精在食物基质中的耐受性。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，BMI 18-30kg/m2），以估计与胃肠道不良症状相关的耐受阈值。协议总结;医疗检查访问。4次研究访视食用含有10、20、30或50克纤维素糊精的食品（分别在研究访视1-4次）至少间隔一周的访视在食用后9小时内完成食欲和肠道症状的视觉模拟量表在每次访视前一天和之后48小时内记录饮食和肠道症状日记研究2 -纤维素糊精的消化和发酵除了人工肠道研究外，拟在16名健康非肥胖志愿者（年龄18-40岁，体重指数18-30kg/m2）中开展一项体内研究，评估纤维素糊精与蔗糖和聚葡萄糖的消化和发酵情况。纤维素糊精的剂量将根据耐受性研究确定（研究1）。呼气样本将被收集用于氢评估，并将被收集动化静脉血用于葡萄糖和胰岛素分析。协议总结;医疗检查访问。研究访问随机、交叉、双盲研究设计食用含有纤维素糊精、聚葡萄糖或蔗糖（碳水化合物含量匹配）的食品收集呼吸和血液样本在食用后5小时内完成食欲和肠道症状的视觉模拟量表在每次访问后48小时的饮食和肠道症状日记研究3 -纤维素糊精和食欲这项研究将测试作为早上零食食用的纤维素糊精的效果。对16名健康非肥胖男性志愿者（年龄18-40岁，体重指数18-30kg/m2）的主观食欲、下一餐随后的能量摄入和肠促胰岛素激素进行了研究。纤维素糊精的剂量将根据耐受性研究确定（研究1）。将含有纤维素糊精的食品与含有可消化（蔗糖）和不可消化（聚葡萄糖）碳水化合物（匹配碳水化合物含量）的食品进行比较。除此之外，该产品在每种情况下都是相同的，蛋白质/脂肪/碳水化合物含量反映了正常的零食，能量含量为200-250千卡。该产品每天食用一次，持续2周，在第1天和第14天评估随意午餐对能量摄入的影响。在每个补充期的第2周记录饮食日记，并在每2周前后测量体重。协议总结;医疗检查访问。6次研究访问（补充前和补充后2周）3次补充期，在随机、交叉、双盲研究设计之间进行2周“洗脱期”多糖或蔗糖（碳水化合物含量匹配）对产品的急性和急性慢性反应在食用后4小时内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，在每个干预期的第2周记录三天的饮食日记

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