NCT04075032已完成不适用
Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients
National Research Council, Spain2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月10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
- 60
- 试验地点
- 2
- 主要终点
- Change (1 log units) of Bacteroidetes per gram of feces
研究概览
简要总结
The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Body mass index >30 kg/m2 or waist circumference >94/80 cm (males/females) in European-Caucasians subjects, plus two of the following:
- •Triglycerides >150 mg/dL or under treatment against hypertrigliceridemia.
- •Fasting glucose ≥100 mg/dL
- •Diagnosed type 2 diabetes mellitus
- •HDL-cholesterol (mg/dl) <40/50 (males/females) or under treatment against low HDLc values.
- •Systolic blood pressure >130 mmHg o diastolic blood pressure >85 mmHg, or under anti-hypertensive drug treatment.
排除标准
- •Age under 18 years
- •Pregnancy or breastfeeding
- •Antibiotic treatment within one month before inclusion in the trial
- •Pomegranate allergy or intolerance (known or suspected)
- •Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)
- •Malignancies
- •Consumption of botanicals or dietary supplements within one month before the inclusion and during the trial.
- •Consumption of ellagitannin-rich sources within one week before the inclusion and during the trial (pomegranate, walnuts, strawberries, raspberries, tea, blackberries and oak-aged wine).
结局指标
主要结局
Change (1 log units) of Bacteroidetes per gram of feces
时间窗: Change from baseline at 30 days vs placebo
Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)
次要结局
- Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).(Changes from baseline at 30 days vs placebo)
- Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)(Changes from baseline at 30 days vs placebo)
- Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).(Changes from baseline at 30 days vs placebo)
- Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)(Changes from baseline at 30 days vs placebo)
- Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)(Changes from baseline at 30 days vs placebo)
- Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases(Baseline values at inclusion)
研究者
Juan Carlos Espín de Gea
Research Professor
National Research Council, Spain
研究点 (2)
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