NCT03101436已完成不适用
Extra Virgin Olive Oil and Red Wine Polyphenols in the Modulation of Fecal Microbiota: an Interventional Study
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud0 个研究点目标入组 20 人开始时间: 2015年2月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Microbiota Changes
研究概览
简要总结
In this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese patients (body mass index (BMI= or > 30kg/m2) with high insulin resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) > 5.
- •Lean subjects (BMI< 28kg/m2) with low insulin resistance (HOMA-IR< 3.3).
排除标准
- •(all patients):
- •Type 2 diabetes
- •Acute or chronic infection
- •Inflammatory disease or endocrine disorders.
- •History of cancer.
- •Anti-inflammatory, corticosteroid, hormone, or antibiotic drug treatment
- •A history of alcohol abuse or drug dependence
- •A restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
- •Intake of prebiotics, probiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.
结局指标
主要结局
Microbiota Changes
时间窗: 1 month
Changes in microbiome composition
次要结局
- Insulin Resistance(1 Month)
- Trimethylamine N-oxide (TMAO) production(1 month)
- Lipid Profile(1 Month)
研究者
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