Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects (POMEcardio)
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)
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.
研究概览
地位
条件
干预/治疗
- 膳食补充剂：Pomegranate extract-first dose-Group A
- 膳食补充剂：Pomegranate extract-first dose-Group B
- 膳食补充剂：Pomegranate extract-second dose-Group A
- 膳食补充剂：Pomegranate extract-second dose-Group B
- 膳食补充剂：Placebo-first dose-Group B
- 膳食补充剂：Placebo-first dose-Group A
- 膳食补充剂：Placebo-second dose-Group B
- 膳食补充剂：Placebo-second dose-Group A
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Murcia、西班牙、30107
- UCAM (San Antonio Catholic University from Murcia)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 40-65 years
- Body mass index (BMI) >27 kg/m2
- Healthy status (no illness in the previous 3-months).
Exclusion Criteria:
- Smoking.
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Pomegranate extract
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
其他名称：
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
其他名称：
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
其他名称：
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
其他名称：
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安慰剂比较：Placebo
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group B will consume 1 daily capsules of placebo for 3 weeks.
其他名称：
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
其他名称：
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
其他名称：
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in serum oxidized LDL-cholesterol concentration
大体时间：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on circulating levels of oxidized particles of LDL-cholesterol
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in serum lipids and lipoproteins levels
大体时间：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in serum sICAM, sVCAM and hsCRP
大体时间：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in fecal microbiota
大体时间：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Number of volunteers with adverse events as a measure of safety and tolerability
大体时间：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in phenolics and derived metabolites in plasma, feces and urine.
大体时间：Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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合作者和调查者
合作者
调查人员
- 首席研究员：Dr. Juan Carlos Espín, PhD、National Research Council (CEBAS-CSIC, Murcia, Spain)
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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