Long-term Effects of Grape Polyphenols as Modulators of Metabolic Syndrome in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Fasting insulin
研究概览
简要总结
The aim of this is study is to evaluate the long-term effects of grape polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Also, studies on the long-term effect of grape polyphenol on markers of metabolic syndrome have been mostly conducted in animals, so clinical trials on this topic are needed.
详细描述
Fifty supposedly healthy volunteers with at least two cardiometabolic risk factors were recruited. The cardiometabolic risk factors used to select the subjects are described below.
The whole intervention will be divided in 2 periods, control (CTR) and dried and milled grape pomace (GRAPOM). The two periods will have a duration of 6 weeks. During the CTR period, subjects will follow their normal dietary habits and samples will be collected at the beginning and at the end. No proper placebo could be found for the product, so this CTR period was chosen. During the GRAPOM period, the subjects will daily consume 8 g of the product solved in water and samples will be collected at the beginning and at the end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least two of the following requirements:
- •BMI ≥ 25 kg/m
- •Fasting glucose values ≥ 100 mg/dL.
- •Triglycerides ≥ 150 mg/dL.
- •HDL-cholesterol: ≤ 50 mg/dL women, ≤ 40 mg/dL men.
- •Blood pressure: systolic ≥ 130 mm Hg or diastolic ≥ 85 mm Hg.
排除标准
- •Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- •Volunteers participating in other studies or weight loss plans.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Fasting insulin
时间窗: Up to three months
Changes of blood insulin fasting levels as result of long-term supplementation with grape pomace (GRAPOM).
Fasting glucose
时间窗: Up to three months
Changes of blood glucose fasting levels as result of long-term supplementation with grape pomace (GRAPOM).
次要结局
- Postprandial insulin(Up to four months)
- Postprandial glucose(Up to four months)
- Blood pressure(Up to four months)
- Blood C reactive protein(Up to five months)
- Blood fibrinogen(Up to five months)
- Blood cholesterol (total, HDL, LDL)(Up to four months)
- Blood triglycerides(Up to four months)
- Iron metabolism(Up to six months)
- miRNA expression(Up to eight months)
- Blood uric acid(Up to five months)
- Profile of fecal microbiota(Up to nine months)
- Blood polyphenols(Up to six months)
- Urine polyphenols(Up to seen months)
- Body fat(Up to seven months)
- Urine uric acid(Up to six months)
- Body weight(Up to three months)
研究者
Jara Pérez-Jiménez
PhD
National Research Council, Spain