Hartman Terryl J, Christie Jennifer, Wilson Annette, Ziegler Thomas R, Methe Barbara, Flanders William Dana, Rolls Barbara J, Loye Eberhart Blaine, Li Jia V, Huneault Helaina, Cousineau Ben, Perez Miriam R, O'Keefe Stephen J D
Department of Epidemiology, Rollins School of Public Health and Winship Cancer Institute, Emory University, Atlanta, Georgia, USA
Nutrition and Health Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
BMJ Open. 2024 Feb 5;14(2):e081379. doi: 10.1136/bmjopen-2023-081379.
Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).
METHODS/DESIGN: This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1-3 and one meal/day in months 4-6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1-2 pounds per week.
The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).
NCT04780477.
最近发表的研究支持食用富含纤维的豆类（如煮熟的干豆）对改善代谢健康和降低癌症风险的有益作用。在超重/肥胖且有结肠息肉病史的参与者中，“富含纤维食物治疗肥胖和预防结肠癌”随机临床试验将测试以豆类为特色的高纤维饮食是否能同时促进体重减轻并抑制结直肠癌（CRC）的结肠黏膜生物标志物。
方法/设计：本研究旨在描述以下方面的变化：（1）体重；（2）胰岛素抵抗和全身炎症的生物标志物；（3）粪便微生物组和代谢组的组成及功能概况；（4）CRC风险的黏膜生物标志物；（5）肠道转运。将招募约60名在过去3年内有非癌性腺瘤性息肉病史的超重或肥胖成年人，并将其随机分配到两种减肥饮食方案中的一种。在为期1周的导入期后，干预组的参与者将在第1至3个月每天两餐食用预先分配好的富含高纤维豆类的主菜，在第4至6个月每天一餐。在对照组中，主菜将用瘦肉蛋白来源（如鸡肉）替代豆类。两组都将接受面对面和书面指导，包括摄入营养均衡的配菜，以每周减重1至2磅。
美国国立卫生研究院通过授予埃默里大学的一项国家癌症研究所资助（5R01CA245063）为这项为期5年的正在进行的研究提供资金，匹兹堡大学获得了一笔分包合同。该研究方案已获得埃默里机构审查委员会的批准（IRB批准号：00000563）。
NCT04780477。
