Abstract

Study part 1 was executed as a randomized double-blind placebo-controlled crossover study and study part 2 as a longitudinal study. Forty-one healthy adult volunteers aged 18-24 years were recruited from the student population of the University of Salford. All subjects enrolled and completed study part 1 and 39 subjects enrolled and completed study part 2. In study part 1, individuals consumed, in random order 0, 20, 40, 60, 80, 100 or 120 g of a RRM containing starch product incorporated in pre-prepared foods on individual test days. Assuming a minimum content of 50% RRM in the starch product this delivered respectively 0, 10, 20, 30, 40, 50 or 60 g of RRM. All foods were prepared and coded by personnel not involved in carrying out the tests. Test days were separated by 7 day washout periods. In study part 2, consumption of RRM was increased from 3.6 g at day 1 in incremental doses up to each subject's MNED as determined in study 1, to be achieved at day 14. Subsequently, RRM intake was from day 15-21 in a way that the final intake at day 21 was at least 10 g above the individual MNED. In both parts of the study, subjects reported the prevalence and magnitude of GI symptoms. No significant change was observed in either defecation frequency and faecal consistency or the number of subjects experiencing any GI symptoms, following consumption of foods containing 0-60 g RRM. The individual MNED at which an increase in symptoms did not occur was determined as 60 g RRM for 71% of the subjects who participated in study part 1. Regression analysis showed that consumption of gradually increasing doses of RRM in food products over 21 days was associated with a significant increase in the mean symptom score for flatulence (P=1.5 x 10(-4)), total bowel movement frequency (P=0.023) and bowel movement frequency to pass watery faeces (P=0.0157). Increasing the ingested dose of RRM by 10 g above the predetermined MNED, however, did not provoke significant increases in GI symptoms. In both studies, the majority of symptom responses were classified by the subjects as 'little more than usual'. Consumption of up to 60 g RRM is tolerated well by most individuals with no evidence of any significant dose-dependent increase in the magnitude of symptoms or the occurrence of multiple GI symptoms. However, a mild laxative effect when consuming >60 g RRM is suggested. Although there was no change in GI responses following consumption of increasing doses of RRM over 21 days, generally a dose of 10 g RRM above the MNED level was tolerated well during medium term intake.

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