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临床试验/NCT06137248
NCT06137248已完成2 期

Randomized Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption

University of Florida1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年2月28日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
76
试验地点
1
主要终点
Change in the hydrogen sulfide-metabolizing species of bacteria

研究概览

简要总结

This study will investigate whether short-term daily energy drink consumption results in an increase in hydrogen sulfide-producing bacteria in adults 18-40 years old.

详细描述

Colorectal cancer (CRC) is the 2nd leading cause of cancer deaths in the US. The bulk of new diagnoses typically occurs after the age of 50 for those without personal or family histories of this disease. However, rates of colorectal cancer have been slowly increasing in incidence in those younger than 50, recently prompting the U.S. Preventative Services Task Force to recommend reducing the age of routine screening to 45. The reason for the rising incidence of CRC in younger individuals (eoCRC) is unclear but with many speculative causes postulated. One of the most frequently cited possible causes relates to changes in the young adult colonic microbiome which either removes a protective mechanism or promotes a carcinogenic process. The latter is the hypothesis being persued.

Certain commensal bacteria produce hydrogen sulfide (H2S) during fermentation of sulfate containing compounds such as sulfur amino acids. For example, Fusobacterium nucleatum produces H2S from metabolizing methionine and cysteine. Atopobium parvulum is another potent H2S producer and is implicated in halitosis. Importantly, H2S has the capacity to induce inflammation and possesses genotoxic and potentially pro-tumorigenic properties, particularly when consistently present over a prolonged period of time. While Fusobacterium and Atopobium are minor members of the normal gut microbiota, recent studies showed that they are overrepresented in CRC patients. The invvestigators published that the relative abundance of A. parvulum was positively correlated with the severity of pediatric inflammatory bowel disease (IBD). Moreover, the investigators observed that Il10-/- mice colonized by A. parvulum developed severe colitis, which was attenuated by a chow diet containing the H2S scavenger bismuth. Together, this data suggests that bacteria-derived H2S may contribute to intestinal pathologies including the creation of a pro-inflammatory and pro-carcinogenic environment, which could be modulated by availability of dietary sulfur contents.

One major energy source for H2S producing gut microbiota is taurine, an essential amino acid found in very high levels/concentrations in energy drinks. The typical American diet provides between 123 and 178 mg of taurine daily. However, consumption of one 8-oz energy drink can increase the average taurine intake 6 to 16 times that our regular diet. The hypothesis being persued is that energy-drinks, through their high taurine content, favors expansion of already present bacteria producing H2S, thereby representing an association with a carcinogenic risk-factor that might help explain the rise in eoCRC cases and developing future interventions to mitigate this risk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults ≥ 18 years of age AND ≤ 40 years of age
  • •Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
  • •Subject willing to complete/comply with study required specimen and survey assessments
  • •Current energy drink consumption of ≤2 energy drinks weekly
  • •Written informed consent obtained from the subject to participate in two companion biobanks: 1) Dr. Thomas George's Tumor and Biospecimen Sample Biobank and 2) Dr. Ryan Thomas's Microbiorepository for future research.

排除标准

  • •Personal history of colorectal cancer (CRC)
  • •Inflammatory Bowel Disease (IBD)
  • •Chronic diarrhea or other chronic gastrointestinal (GI) problems felt to interfere with study conduct per the PI
  • •Regular (daily) intake of probiotics
  • •Oral or IV antibiotic use within the past 28 days (prior to intervention start date)
  • •Known intolerance of or sensitivity to caffeine
  • •Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  • •Known pregnancy at the time of enrollment

研究组 & 干预措施

Energy drink intervention

Experimental

干预措施: Energy drink (Dietary Supplement)

Control arm

No Intervention

Participants on this arm will only consume their normal diet for 4 weeks.

结局指标

主要结局

Change in the hydrogen sulfide-metabolizing species of bacteria

时间窗: 4 weeks

Determine the change in the hydrogen sulfide-metabolizing species of bacteria in those receiving the energy drink intervention compared to the control group, as measured by the change from baseline to 1 month post-intervention in the sulfur-metabolizing bacterial communities value in the stool

次要结局

  • Overall change in microbial diversity(4 weeks)
  • Microbiome changes(4 weeks)
  • Microbiome changes and tolerance(4 weeks)
  • Changes in colonic microbiota(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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