Randomized Controlled Trial of Resistant Starch to Reduce Colon Cancer Risk in Alaska Native People
抗性淀粉降低阿拉斯加原住民结肠癌风险的随机对照试验
基本信息
- 批准号:9236731
- 负责人:
- 金额:$ 59.14万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2017
- 资助国家:美国
- 起止时间:2017-01-10 至 2021-12-31
- 项目状态:已结题
- 来源:
- 关键词:Adenomatous PolypsAdultAfricanAfrican AmericanAlaskaAlaska NativeAmmoniaAntineoplastic AgentsApoptosisBile AcidsBilophilaBiological MarkersBiopsyBloodButyratesCASP3 geneCD3 AntigensCarcinogen exposureCarcinogensCessation of lifeCleaved cellClinicalClinical TrialsClostridium symbiosumColon CarcinomaColonic PolypsColonoscopyConsumptionDevelopmentDietDoseDouble-Blind MethodEatingEndoscopic BiopsyEpigenetic ProcessEubacteriumExhibitsExposure toFOXP3 geneFatty acid glycerol estersFermentationFiberFish OilsFlow CytometryFoodFoundationsFusobacterium nucleatumGenesGeneticGoalsHealthHeterocyclic AminesHumanImmunohistochemistryIncidenceIndolesInflammationInflammatoryIntakeInterventionInvestmentsLamina PropriaLymphocyteMaizeMalignant NeoplasmsMeasuresMeatMicrobeMolecularMucous MembraneMusNative-BornNatureNeoplasmsNeoplastic Cell TransformationOmega-3 Fatty AcidsParticipantPhenolsPilot ProjectsPolycyclic HydrocarbonsPopulationPreventionProductionPropertyRandomizedRandomized Controlled TrialsRecurrenceRegulatory T-LymphocyteReportingResearchResistanceRibosomal RNARiskRuralSigmoidoscopySmokeSpectrometryStaining methodStainsStarchSulfhydryl CompoundsSupplementationTestingTimeTobaccoToxic Environmental SubstancesTranslatingVolatile Fatty Acidsagedanticancer researcharmcancer biomarkerscancer riskcarcinogenicitycostdesignfeedingfood consumptionhigh riskimprovedintraepitheliallactic acid bacteriamacrophagemalignant colon tumormathematical modelmetabolomemicrobialmicrobiotamiddle ageminimal riskmortalitynext generation sequencingprebioticspreventrRNA Genesresponsescreeningsoluble fiberunderserved minorityurinaryweek trialwestern diet
项目摘要
Alaska Native people (AN), an underserved minority US population, have the highest reported incidence
(91:100,000) and death (~35:100,000) rate from colon cancer in the world. There is overwhelming
experimental and human evidence that diet drives cancer risk, irrespective of genetic background. The World
Cancer Research Foundation found convincing evidence that meat increases cancer risk, and that fiber
suppresses it [2, 3]. Consequently, the high risk in AN may be attributed to their remarkably low fiber (8g/d)
and high meat consumption. We hypothesize that their extreme risk results from the combined effects of fiber
deficiency, resulting in decreased colonic microbiota production of anti-cancer butyrate, plus the high exposure
to carcinogens derived from meat, fat, smoked foods and tobacco. To explore this hypothesis, we will conduct a
randomized double-blinded 4-week clinical trial in up to 100 randomizable healthy, middle-aged AN
undergoing screening colonoscopy, with the objective of obtaining 60 completed interventions. The
interventions will consist of either a high-dose `indigestible' resistant starch fiber supplement (42g/d) given as
a drink, which will increase their daily intake to >50g/d, or a control `digestible' starch drink. To gauge
potential efficacy against cancer development we will use proliferative biomarkers which can be measured
sequentially in colonic mucosa obtained by sigmoidoscopy biopsy (primary endpoint). At the same time, we
will investigate the mechanisms responsible for these anticipated changes by measuring the colonic microbiota
composition and activity by next generation sequencing of microbial 16S-rRNA genes, and its metabolome by
NMR, UPLC-M, and GC-M spectrometry, interpreted with advanced mathematical modeling. We are confident
that we will achieve our endpoint because we are using a much higher dose of fiber than has been used in
previous clinical trials at >50g/d, which is the level shown to be associated with minimal risk in rural Africans.
Secondly, we expect that the continued high fish oil consumption by AN will enhance their responsiveness to
fiber supplementation. The conduct of this molecular proof-of-concept study is essential before the conduct of
a large-scale definitive clinical trial of high dose fiber supplementation in the prevention of colonic polyps and
cancer. While the long-term goal will be to increase the consumption of fiber-rich foods, low cost resistant
starch supplementation may offer an immediate strategy to save lives in Alaska Native people, and also in high
risk African Americans and the growing populations across the globe consuming low fiber Western diets.
!
阿拉斯加原住民(AN)是美国服务不足的少数民族,据报道发病率最高
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Stephen J.D. O'Keefe其他文献
The influence of intravenous nutrition on protein dynamics following surgery.
静脉营养对手术后蛋白质动力学的影响。
- DOI:
10.1016/0026-0495(81)90034-2 - 发表时间:
1981 - 期刊:
- 影响因子:0
- 作者:
Stephen J.D. O'Keefe;Stephen J.D. O'Keefe;L. Moldawer;L. Moldawer;Vernon R. Young;Vernon R. Young;G. L. Blackburn;G. L. Blackburn - 通讯作者:
G. L. Blackburn
In vivo demonstration of nitrogen-sparing mechanisms for glucose and amino acids in the injured rat.
受伤大鼠体内葡萄糖和氨基酸的氮保留机制的演示。
- DOI:
10.1016/0026-0495(80)90143-2 - 发表时间:
1980 - 期刊:
- 影响因子:0
- 作者:
L. Moldawer;Stephen J.D. O'Keefe;Albert Bothe;B. Bistrian;G. L. Blackburn - 通讯作者:
G. L. Blackburn
Stephen J.D. O'Keefe的其他文献
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{{ truncateString('Stephen J.D. O'Keefe', 18)}}的其他基金
Diet and Gastrointestinal Cancer Risk in African Americans and Rural Africans
非裔美国人和非洲农村人的饮食和胃肠癌风险
- 批准号:
7656516 - 财政年份:2009
- 资助金额:
$ 59.14万 - 项目类别:
Diet and Gastrointestinal Cancer Risk in African Americans and Rural Africans
非裔美国人和非洲农村人的饮食和胃肠癌风险
- 批准号:
8033159 - 财政年份:2009
- 资助金额:
$ 59.14万 - 项目类别:
Diet and Gastrointestinal Cancer Risk in African Americans and Rural Africans
非裔美国人和非洲农村人的饮食和胃肠癌风险
- 批准号:
8213627 - 财政年份:2009
- 资助金额:
$ 59.14万 - 项目类别:
DIET, COLONIC BACTERIAL METABOLISM AND COLON CANCER RISK IN AFRICAN AMERICANS
非裔美国人的饮食、结肠细菌代谢和结肠癌风险
- 批准号:
7201109 - 财政年份:2005
- 资助金额:
$ 59.14万 - 项目类别:
Diet, Colonic Bacterial Metabolism and Colon Cancer Risk in African-Americans
非裔美国人的饮食、结肠细菌代谢和结肠癌风险
- 批准号:
7040952 - 财政年份:2003
- 资助金额:
$ 59.14万 - 项目类别:
Diet, Disease, and Pancreatic Enzyme Secretions in Humans
人类的饮食、疾病和胰酶分泌
- 批准号:
7040932 - 财政年份:2003
- 资助金额:
$ 59.14万 - 项目类别:
DIET, DISEASE, AND PANCREATIC ENZYME SYNTHESIS IN HUMANS
人类的饮食、疾病和胰腺酶合成
- 批准号:
6517635 - 财政年份:2000
- 资助金额:
$ 59.14万 - 项目类别:
DIET, DISEASE, AND PANCREATIC ENZYME SYNTHESIS IN HUMANS
人类的饮食、疾病和胰腺酶合成
- 批准号:
6381590 - 财政年份:2000
- 资助金额:
$ 59.14万 - 项目类别:
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