Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change inintestinal permeability
研究概览
简要总结
This study will investigate the effects of curcumin on the structure/function of the body by investigating whether targeted improvement of intestinal barrier function by supplementation with oral curcumin will result in attenuation of lipopolysaccharide (LPS) translocation and/or intestinal inflammation.
详细描述
A typical diet in the United States, also known as Western diet, is very high in sugars and saturated fat, and poor in food such as fruits, vegetables, fish and whole grains. This type of diet is associated with higher risk to develop obesity and other health problems such as high blood pressure, high cholesterol, Type 2 diabetes, and heart disease. Western diet can also cause changes in the gut that allow bacteria that are typically only present in the gut to leak out into the bloodstream. It is thought that having gut bacteria in the bloodstream may play a role in the development of diseases like Type 2 diabetes and heart disease.
Curcumin is a dietary supplement that comes from the root of the turmeric plant, and it may have an effect on the function of the gut and the leakage of gut bacteria into the bloodstream. The purpose of this research study is to evaluate the effects of daily curcumin dietary supplements on the function of the gut in subjects who are at risk for cardiovascular and metabolic diseases, for example they have increased blood pressure, increase waist circumference and high triglycerides (fat in the blood).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Based on National Institutes of Health (NIH) definition of Metabolic syndrome, the subject must meet at least 3 of the following criteria:
- •A. Waist Circumference: Female ≥ 88 cm, Male ≥ 102 cm B. Blood Pressure: ≥ 130/85 mm/Hg and/or treatment with blood pressure lowering medication C. Impaired fasting glucose or HbA1c (fasting glucose ≥ 100 mg/dl or HgA1c ≥ 5.7 D. HDL-C: Females< 50 mg/dl, Males < 40 mg/dl E. Triglycerides ≥ 150 mg/dl
- •Willing and able to comply with the study protocol
排除标准
- •Established cardiovascular disease
- •Pre-existing liver disease other than NAFLD
- •Chronic kidney disease (Stage 4 and 5)
- •Rheumatological disease
- •Active malignancy
- •Alcohol consumption greater than 7 drinks per week for females and greater than 14 drinks per week for males
- •Current use of metformin and/or steroids
- •Curcumin supplementation
- •Females of child-bearing potential (NOT of child-bearing potential is defined as s/p hysterectomy or post-menopausal.)
- •Prisoners/wards of the state and individuals with limited English proficiency
结局指标
主要结局
Change inintestinal permeability
时间窗: Baseline to 12 months
Measured by level plasma lipopolysaccharide (LPS). A reduction in LPS suggests a reduction in intestinal permeability
Change in intestinal barrier function
时间窗: Baseline to 12 months
Measured by level of excreted Zonulin in stool samples. A reduction in Zonulin suggests a reduction in intestinal barrier function
次要结局
未报告次要终点