Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in serum oxidized LDL-cholesterol concentration
研究概览
简要总结
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-65 years
- •Body mass index (BMI) >27 kg/m2
- •Healthy status (no illness in the previous 3-months).
排除标准
- •Pregnancy/lactation.
- •Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- •Previous gastrointestinal surgery
- •Recent use of antibiotics (within 1-month prior to the study)
- •Suspected hypersensitivity to pomegranate or any of its components
- •Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- •Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- •Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
结局指标
主要结局
Change in serum oxidized LDL-cholesterol concentration
时间窗: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Effect on circulating levels of oxidized particles of LDL-cholesterol
次要结局
- Change in serum lipids and lipoproteins levels(Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks)
- Change in phenolics and derived metabolites in plasma, feces and urine.(Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks)
- Change in fecal microbiota(Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks)
- Change in serum sICAM, sVCAM and hsCRP(Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks)
- Number of volunteers with adverse events as a measure of safety and tolerability(Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks)
研究者
Juan Carlos Espín de Gea
Full Research Professor
National Research Council, Spain