Storey D, Lee A, Bornet F, Brouns F
Bioscience Research Institute, The University of Salford, Salford M5 4WT, Greater Manchester, UK.
Eur J Clin Nutr. 2007 Nov;61(11):1262-70. doi: 10.1038/sj.ejcn.1602642. Epub 2007 Feb 7.
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.
研究的第一部分采用随机双盲安慰剂对照交叉试验设计，第二部分采用纵向研究设计。
从索尔福德大学的学生群体中招募了41名年龄在18 - 24岁之间的健康成年志愿者。所有受试者均登记并完成了研究的第一部分，39名受试者登记并完成了研究的第二部分。
在研究的第一部分，受试者在各个测试日以随机顺序食用0、20、40、60、80、100或120克含有抗性淀粉（RRM）的淀粉产品，这些产品被添加到预先准备好的食物中。假设淀粉产品中RRM的最低含量为50%，则分别提供了0、10、20、30、40、50或60克的RRM。所有食物均由不参与测试的人员制备和编码。测试日之间间隔7天的洗脱期。在研究的第二部分，RRM的摄入量从第1天的3.6克开始递增，直至达到研究1中确定的每个受试者的最低有效剂量（MNED），该剂量将在第14天达到。随后，从第15天至21天的RRM摄入量应使第21天的最终摄入量比个体的MNED至少高10克。在研究的两个部分中，受试者均报告了胃肠道症状的发生率和严重程度。
食用含有0 - 60克RRM的食物后，排便频率、粪便稠度或出现任何胃肠道症状的受试者数量均未观察到显著变化。对于参与研究第一部分的71%的受试者，未出现症状增加的个体最低有效剂量（MNED）被确定为60克RRM。回归分析表明，在21天内逐渐增加食品中RRM剂量的摄入与肠胃胀气的平均症状评分显著增加相关（P = 1.5×10⁻⁴）、总排便频率（P = 0.023）以及排出水样粪便的排便频率（P = ）。然而，将RRM的摄入剂量比预定的MNED增加10克，并未引发胃肠道症状的显著增加。在两项研究中，大多数症状反应被受试者归类为“比平常稍多一点”。
大多数人对摄入高达60克的RRM耐受性良好，没有证据表明症状严重程度有任何显著的剂量依赖性增加或出现多种胃肠道症状。然而，建议摄入超过60克RRM时会有轻微的通便作用。尽管在21天内摄入递增剂量的RRM后胃肠道反应没有变化，但在中期摄入期间，一般比MNED水平高10克的RRM剂量耐受性良好。 0.0157
