背景:膳食纤维(DF)摄入不足与几种人类疾病有关。面包通常被消费,通过掺入脱脂米糠(DRB)可以增加其DF含量。
目的:这项关于DRB强化面包的首次人体研究主要旨在评估DRB强化面包对粪便样品中关键微生物属和物种复合物相对丰度的影响。次要结果包括临床(心血管风险概况),患者报告(每日面包消耗和排便,肠道舒适,总体福祉,和总DF摄入量),生物学(粪便微生物群基因丰度,以及粪便和血浆代谢物),和生理(全肠和区域运输时间和气体发酵概况)结果在低DF摄入量的健康成年人。
方法:这是一个双臂,安慰剂对照,双盲,交叉随机对照试验。研究持续时间为14周:2周的导入,每期干预4周,2周的冲洗,和2周的随访。总的来说,克赖斯特彻奇招募了60名DF摄入量低的健康成年人(每天<18克[女性]或<22克[男性]),新西兰,2022年6月至12月。随机分配的参与者每天食用3片(女性个体)或4片(男性个体)DRB强化面包,然后食用安慰剂面包,反之亦然。DRB强化面包提供8g(女性个体)或10.6g(男性个体)的总DF,而安慰剂(匹配的商业白吐司面包)提供2.7g(女性个体)或3.6g(男性个体)的总DF。在每个干预阶段之前和之后,参与者提供粪便和血液样本以评估生物反应;完成为期3天的食物日记以评估通常摄入量和基于网络的问卷以评估肠道舒适度,一般和心理健康,每日面包摄入量,通过应用程序进行排便;进行了人体测量和血压测量;并喝了蓝色食物染料以评估整个肠道运输时间。此外,25%(15/60)的参与者摄入了Atmo气体感应胶囊,以评估结肠气体发酵状况以及整个肠道和区域运输时间。将比较DRB组和安慰剂组之间与基线的平均差异,以及组内(干预后与基线)。对于代谢组分析,将使用干预后的值在组内和组间进行比较.
结果:初步分析包括56名参与者(n=33,59%为女性;n=23,41%为男性)。由于大数据集,数据分析计划在2024年最后一个季度前全部完成,完整结果预计将在2024年底前发表在同行评审期刊上.
结论:这项首次人类研究为食用DRB强化面包以有效调节促进健康的肠道微生物的前景提供了见解。它们的新陈代谢,和DF摄入量低的健康成年人。
背景:澳大利亚新西兰临床试验注册中心ACTRN12622000884707;https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383814。
■DERR1-10.2196/59227。
BACKGROUND: Inadequate dietary fiber (DF) intake is associated with several human diseases.
Bread is commonly consumed, and its DF content can be increased by incorporating defatted rice bran (DRB).
OBJECTIVE: This first human study on DRB-fortified
bread primarily aims to assess the effect of DRB-fortified
bread on the relative abundance of a composite of key microbial genera and species in fecal samples. Secondary outcomes include clinical (cardiovascular risk profile), patient-reported (daily
bread consumption and bowel movement, gut comfort, general well-being, and total DF intake), biological (fecal microbiota gene abundances, and fecal and plasma metabolites), and physiome (whole-gut and regional transit time and gas fermentation profiles) outcomes in healthy adults with low DF intake.
METHODS: This is a 2-armed, placebo-controlled, double-blinded, crossover randomized controlled trial. The study duration is 14 weeks: 2 weeks of lead-in, 4 weeks of intervention per phase, 2 weeks of washout, and 2 weeks of follow-up. Overall, 60 healthy adults with low DF intake (<18 g [female individuals] or <22 g [male individuals] per day) were recruited in Christchurch, New Zealand, between June and December 2022. Randomly assigned participants consumed 3 (female individuals) or 4 (male individuals) slices of DRB-fortified bread per day and then placebo
bread, and vice versa. The DRB-fortified bread provided 8 g (female individuals) or 10.6 g (male individuals) of total DF, whereas the placebo (a matched commercial white toast bread) provided 2.7 g (female individuals) or 3.6 g (male individuals) of total DF. Before and after each intervention phase, participants provided fecal and blood samples to assess biological responses; completed a 3-day food diary to assess usual intakes and web-based questionnaires to assess gut comfort, general and mental well-being, daily bread intake, and bowel movement via an app; underwent anthropometry and blood pressure measurements; and drank blue food dye to assess whole-gut transit time. Additionally, 25% (15/60) of the participants ingested Atmo gas-sensing capsules to assess colonic gas fermentation profile and whole-gut and regional transit time. Mean differences from baseline will be compared between the DRB and placebo groups, as well as within groups (after the intervention vs baseline). For metabolome analyses, comparisons will be made within and between groups using postintervention values.
RESULTS: Preliminary analysis included 56 participants (n=33, 59% female; n=23, 41% male). Due to the large dataset, data analysis was planned to be fully completed by the last quarter of 2024, with full results expected to be published in peer-reviewed journals by the end of 2024.
CONCLUSIONS: This first human study offers insights into the prospect of consuming DRB-fortified bread to effectively modulate health-promoting gut microbes, their metabolism, and DF intake in healthy adults with low DF intake.
BACKGROUND: Australian New Zealand Clinical Trials Registry ACTRN12622000884707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383814.
UNASSIGNED: DERR1-10.2196/59227.