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

13TSB_N4L2CRD：CELLDEX-低热量散装糖替代品的开发

基本信息

批准号：
BB/L025019/1
负责人：
Ian Macdonald
金额：
$ 31.08万
依托单位：
University of Nottingham
依托单位国家：
英国
项目类别：
Research Grant
财政年份：
2014
资助国家：
英国
起止时间：
2014 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=BB%2FL025019%2F1
关键词：
13TSB_N4L2CRD CELLDEX Developement low calorie

项目摘要

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

研究1 -纤维糊精的耐受性这主要是一项描述性研究，以验证在食物基质中消耗的单次递增剂量（10 g、20 g、30 g、50 g）纤维糊精的耐受性。招募6名健康、非肥胖男性和6名女性志愿者（年龄18- 40岁，BMI 18- 30 kg/m2），以估计不良GI症状的耐受阈值。方案总结;医学筛选访视。4次研究访视食用含有10，20，30或50 g纤维糊精（分别在研究访视1-4时）访视间隔至少一周完成进食后9小时食欲和肠道症状的视觉模拟量表在每次访视前一天和访视后48小时保存饮食和肠道症状日记研究2 -纤维糊精的消化和发酵除了人工肠道研究之外，还建议在16名健康、非肥胖志愿者（男性/女性，年龄18- 40岁，BMI 18- 30 kg/m2）中进行体内研究，评估纤维糊精与蔗糖和聚葡萄糖相比的消化和发酵。将根据耐受性研究（研究1）确定纤维糊精的剂量。将采集呼吸样本进行氢评估，并采集动脉化静脉血进行葡萄糖和胰岛素分析。方案总结;医学筛选访视。3x研究访视随机、交叉、双盲研究设计食用含有纤维糊精、聚葡萄糖或蔗糖的食品（碳水化合物含量匹配）呼吸和血液样品的收集进食后5小时完成食欲和肠症状的视觉模拟量表每次访问后保持饮食和肠症状日记48小时研究3 -纤维糊精和食欲该研究将测试纤维糊精的作用，在16名健康的非肥胖男性志愿者（年龄18- 40岁，BMI 18- 30 kg/m2）中，作为上午零食食用，主观食欲，随后的下一餐能量摄入和肠促胰岛素激素。将根据耐受性研究（研究1）确定纤维糊精的剂量。将含有纤维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（碳水化合物含量匹配）的食品进行比较。否则，产品在每种情况下都是相同的，其中蛋白质/脂肪/碳水化合物含量反映了正常的零食和200-250千卡的能量含量。然后每天食用一次该产品，持续2周，并在第1天和第14天评估对自由进食午餐时能量摄入的影响。在每个补充阶段的第2周期间也将保持食物日记，并且在每个2 wk阶段之前和之后测量体重。6次研究访视（在2周补充期之前和之后）3x补充期，其间有2周“洗脱期”随机、交叉、双盲研究设计聚葡萄糖或蔗糖（碳水化合物含量匹配）急性和急性对产品的慢性反应进食后4小时完成食欲和肠道症状的视觉模拟量表饮食和肠道症状在每次访视后保留48小时的日记在每个干预期的第2周保留三天饮食日记