Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol.
Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol.
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DOI：
10.1136/bmjopen-2020-047162
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发表时间：
2021-08-27
期刊：
影响因子：
2.9
通讯作者：
O'Keefe SJD
中科院分区：
文献类型：
--
作者：
Koller KR;Wilson A;Normolle DP;Nicholson JK;Li JV;Kinross J;Lee FR;Flanagan CA;Merculieff ZT;Iyer P;Lammers DL;Thomas TK;O'Keefe SJD
饮食被证明会影响大肠癌（CRC）风险，是可改变的环境因素。肠道菌群发酵的纤维食品不仅可以为结肠上皮提供食物，而且对结肠粘膜炎症和增殖产生调节作用。我们描述了与阿拉斯加本地人（AN）的双盲，随机对照试验中使用的方法，以确定补充饮食纤维是否可以大大降低全球报告CRC发病率最高的人中的CRC风险。
结肠镜检查时，符合条件筛查结肠镜检查同意进行基线评估和标本/数据收集（血液，尿液，粪便，唾液，呼吸和结肠粘膜活检）的患者。经过为期8周的稳定期，结肠镜检查后重新建立了正常的肠道微生物群，研究人员随机将参与者随机将高纤维补充剂（抗性淀粉，n = 30）或安慰剂（可挖掘淀粉，n = 30），重复凳子样品收集。在28天的补充试验中，每个参与者都会食用通常的饮食，并在直接观察下食用补充剂。在第29天，参与者进行柔性乙状结肠镜检查以获取粘膜活检样品，以测量补充剂对癌症风险的炎症和增殖生物标志物的影响，并具有随访评估以及类似于基线的数据/标本/标本。次要结局指标包括高纤维补充剂对口服和结肠微生物组和生物流体代谢组的影响。
批准是从阿拉斯加地区和匹兹堡大学机构审查委员会以及阿拉斯加土著部落卫生联盟和西南中心基金会研究审查机构获得的。在整个研究中，数据安全监控委员会，材料转移协议和每周学习团队会议提供了定期的监督。研究结果将首先与部落领导人，卫生管理员，提供者和社区成员共享。一旦由部落审查机构批准，经过同行评审的期刊文章和会议演讲将即将举行。
NCT03028831。
Diet, shown to impact colorectal cancer (CRC) risk, is a modifiable environmental factor. Fibre foods fermented by gut microbiota produce metabolites that not only provide food for the colonic epithelium but also exert regulatory effects on colonic mucosal inflammation and proliferation. We describe methods used in a double-blinded, randomised, controlled trial with Alaska Native (AN) people to determine if dietary fibre supplementation can substantially reduce CRC risk among people with the highest reported CRC incidence worldwide. Eligible patients undergoing routine screening colonoscopy consent to baseline assessments and specimen/data collection (blood, urine, stool, saliva, breath and colon mucosal biopsies) at the time of colonoscopy. Following an 8-week stabilisation period to re-establish normal gut microbiota post colonoscopy, study personnel randomise participants to either a high fibre supplement (resistant starch, n=30) or placebo (digestible starch, n=30) condition, repeating stool sample collection. During the 28-day supplement trial, each participant consumes their usual diet plus their supplement under direct observation. On day 29, participants undergo a flexible sigmoidoscopy to obtain mucosal biopsy samples to measure the effect of the supplement on inflammatory and proliferative biomarkers of cancer risk, with follow-up assessments and data/specimen collection similar to baseline. Secondary outcome measures include the impact of a high fibre supplement on the oral and colonic microbiome and biofluid metabolome. Approvals were obtained from the Alaska Area and University of Pittsburgh Institutional Review Boards and Alaska Native Tribal Health Consortium and Southcentral Foundation research review bodies. A data safety monitoring board, material transfer agreements and weekly study team meetings provide regular oversight throughout the study. Study findings will first be shared with AN tribal leaders, health administrators, providers and community members. Peer-reviewed journal articles and conference presentations will be forthcoming once approved by tribal review bodies. NCT03028831.
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影响因子：
1.3
作者：
Johnson, Jennifer S.;Nobmann, Elizabeth D.;Lanier, Anne P.
通讯作者：
Lanier, Anne P.
DOI：
10.3945/jn.111.147660
发表时间：
2012-05
期刊：
The Journal of nutrition
影响因子：
--
作者：
Conlon MA;Kerr CA;McSweeney CS;Dunne RA;Shaw JM;Kang S;Bird AR;Morell MK;Lockett TJ;Molloy PL;Regina A;Toden S;Clarke JM;Topping DL
通讯作者：
Topping DL
影响因子：
1.3
作者：
Bersamin, Andrea;Zidenberg-Cherr, Sheri;Luick, Bret R.
通讯作者：
Luick, Bret R.
影响因子：
1.3
作者：
Johnson, Jennifer S.;Nobmann, Elizabeth D.;Lanier, Anne P.
通讯作者：
Lanier, Anne P.
DOI：
10.1158/1078-0432.ccr-13-2483
发表时间：
2014-02-15
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Bultman SJ
通讯作者：
Bultman SJ