The Influence Of Cranberry Juice On Risk Factors For Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in biomarkers of cardiovascular disease and polyphenol absorption
研究概览
简要总结
Previous studies have shown that consumption of a low calorie cranberry beverage imparts a favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men. However, these studies were not well controlled. Thus, it is important to confirm these effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify the cardioprotective effects of cranberries by conducting a dietary intervention trial with healthy subjects in a controlled environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 to 65 years of age
- •BMI 20 to 38 kg/m2
排除标准
- •history of bariatric or certain other surgeries related to weight control
- •kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- •Type 2 diabetes or use of glucose-lowering medication
- •Have a fasting blood sugar greater than 126 mg/dL
- •LDL-cholesterol less than 130 mg/dL
- •fasting triglycerides greater than 300 mg/dL
- •use of cholesterol-lowering medication or supplements
- •use of blood pressure-lowering medication
- •smoking or use of other tobacco products (within 6 months prior to the start of the study)
- •unwillingness to abstain from vitamin, mineral, and herbal supplements for 2 weeks prior to the study and during the study
- •use antibiotics during the study,or for 3 weeks prior to starting the study.
- •history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- •weight loss of >/= 10% of your body weight within the last 12 months or plan to initiate a weight loss program during the next 10 months
- •inability to eat cranberries
- •inability or unwillingness to give informed consent or communicate with study staff
- •self-reported history of alcohol or substance abuse within the past 12 months and/or are currently in treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- •other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
结局指标
主要结局
Change in biomarkers of cardiovascular disease and polyphenol absorption
时间窗: Days 1&2; Days 27&28; Days 55&56
A blood lipid panel will include plasma total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apo A-1, Apo A-II, Apo B, Lpa. Inflammatory markers (IL-6, IL-10, IL-1-alpha, CRP, TNF-alpha, fibrinogen, iCAM) will be determined by ELISA. Serum will be analyzed for polyphenol concentration.
次要结局
- Change from baseline in systolic and diastolic blood pressure(Days 1, 28, and 56)
- Change in urine metabolomics and adhesion analysis(Days 1 & 56)
- Change in fecal microbiota(Days 1 & 56)