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临床试验/NCT05902754
NCT05902754已完成不适用

Broccoli Extract Supplementation and Gastrointestinal Health in Older Adults With Active Alcohol Use and Low Diet Quality

Louisiana State University Health Sciences Center in New Orleans2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change of Inflammation biomarkers

研究概览

简要总结

Chronic alcohol consumption leads to perturbations in gut microbiome balance (dysbiosis) and disruption of gut barrier integrity. As a result, bacteria, toxins, and metabolites can enter the blood stream and reach distant organs, triggering inflammation and oxidative stress. Through this mechanism gut leak is closely related to the onset of metabolic diseases, such as nonalcoholic fatty liver disease (NAFLD) and diabetes.

Despite the prominent role of diet and alcohol in the pathogenesis of metabolic diseases, there is a lack of treatments to mitigate their effects in triggering systemic inflammation and oxidative stress. Novel treatments using generally recognized as safe (GRAS) compounds focused on restoring the intestinal barrier to mitigate metabolite endotoxemia are sorely needed. This project will test the potential of broccoli sprouts extract (BSE) as a GRAS treatment to minimize the combined effect of poor nutrition and alcohol on the gut. Broccoli sprouts are rich in sulforaphane, a bioactive compound derived from the glucosinolate glucoraphanin with anti-inflammatory and antioxidant proprieties. BSE supplementation has been used in preclinical and clinical studies as a health- promoting food, showing significant positive changes in the gut microbiota composition, protection against colitis, cardiometabolic improvement, and lower inflammation. We believe that BSE is a viable alternative therapeutic approach for patients who are resistant to lifestyle changes such as healthy eating and reducing alcohol use. Our purpose is to test BSE supplementation in human subjects with poor nutrition compounded by alcohol use, specifically in older adults who we believe will receive greater benefit from this approach. At the completion of the proposed study, we expect to have determined that treatments using generally recognized as safe (GRAS) compounds can be useful to restore the gut barrier integrity, and as consequence of reduced gut leak we expect to observe lower inflammation and oxidative stress.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Labels of the product will be replaced with "Tablets A" and "Tablets B" labels.

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects ≥ 50 years of age at enrollment.
  • Consume at least 8 alcoholic drinks/week. AUDIT-C score >8.

排除标准

  • Bowel-related diseases
  • Diagnosed Diabetes
  • Allergy or intolerance to broccoli.
  • Any acute illness within the last 6 weeks.
  • Chronic anti-inflammatory use or antibiotic treatment in the last 7 days.
  • Acute illness within the preceding six weeks (defined as fever, new antibiotic use or unscheduled healthcare visit - for illness).
  • Acute alcohol intoxication upon arrival on the day of study visit.
  • Additional exclusion criteria:
  • Any health issue that, the study investigator's judgement, confers excess risk for participation.

研究组 & 干预措施

Sulforaphane tablets

Experimental

People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.

干预措施: Generally Recognized as Safe - Sulforaphane (Dietary Supplement)

Placebo tablets

Placebo Comparator

People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Change of Inflammation biomarkers

时间窗: Change in serum Interleukin-6 levels after 28 days of intervention.

Measured by serum Interleukin-6 level.

Change on the Leaky gut biomarker

时间窗: Change in serum levels of intestine acid biding proteins after 28 days of intervention.

Measured by serum levels of intestine acid biding proteins.

Gut Leak

时间窗: Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.

Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.

次要结局

  • Biomarkers of Inflammation(After 28 days of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aline Zaparte

Principal Investigator

Louisiana State University Health Sciences Center in New Orleans

研究点 (2)

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