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

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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