Effects of Red Grape Juice on the Plasma Metabolome in Chronic Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Plasma Metabolomics Changes
研究概览
简要总结
Previous studies suggest that both RW and red grape juice (RGJ) have beneficial properties upon risk factors and cardiovascular events. However, the effects of grape polyphenols on metabolomics in men are still poorly understood. Recent advances in mass spectroscopy allowed substantial advances in the analysis of molecular signatures of several diseases.
Therefore, the objective of this study is to evaluate the impact of RGJ on plasma metabolomics in patients with chronic coronary disease (CAD). This is a crossover, prospective, randomized and controlled study, with two 3-week interventions: 1. daily consumption of RGJ (400 mL) and 2. total abstention from foods rich in polyphenols. Plasma metabolomics will be performed by gas chromatography (GC)/mass spectroscopy (MS) by (Prof. Labate, Department of Plant Genetics, ESALQ). The sample will consist of 50 patients with chronic CAD. aged between 46 and 69 years. The inclusion and exclusion criteria were defined to achieve homogeneity of the group and avoid interference. The central hypothesis of this study is that RGJ will exert effects upon pathways involved in lipids, carbohidrates and energy production, contributing to the understanding of the mechanisms of action of polyphenols on cardiovascular health, without the risks associated with alcohol.
详细描述
Previous studies have suggested that both red wine and red grape juice exert beneficial effects on cardiovascular health, including reductions in inflammatory biomarkers and cardiovascular events. However, the influence of grape polyphenols on the plasma metabolome in men with chronic coronary artery disease (CAD) remains poorly understood. Human plasma contains a wide range of metabolites that reflect physiological and pathological processes, making metabolomic profiling a valuable approach for investigating the biological effects of dietary interventions. Recent advances in mass spectrometry-based technologies have greatly expanded the ability to characterize these metabolic changes.
This prospective, randomized, controlled crossover study aims to investigate the effects of red grape juice consumption on the plasma metabolome of patients with chronic CAD. Fifty men aged 46 to 69 years with a confirmed diagnosis of chronic CAD will be enrolled. Participants will undergo two 3-week intervention periods in random order: daily consumption of 400 mL of red grape juice and a control period involving complete abstinence from polyphenol-rich foods. Plasma metabolomic profiling will be performed using gas chromatography-mass spectrometry (GC-MS) by Prof. Carlos Labate at the Department of Genetics, Luiz de Queiroz College of Agriculture (ESALQ), University of São Paulo. Eligibility criteria were established to ensure a homogeneous study population and to minimize potential confounding factors. We hypothesize that red grape juice consumption will modulate metabolic pathways involved in lipid metabolism, carbohydrate metabolism, and energy production, providing further insight into the mechanisms by which grape polyphenols promote cardiovascular health without the risks associated with alcohol consumption.
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
- None
入排标准
- 年龄范围
- 46 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 46 and 69 years.
- •Established chronic coronary artery disease, defined by at least one of the following:
- •Acute myocardial infarction occurring more than 30 days before enrollment;
- •Angiographic evidence of ≥50% stenosis in one or more epicardial coronary arteries;
- •Previous percutaneous coronary intervention (PCI);
- •Previous coronary artery bypass grafting (CABG).
- •BMI <30 kg/m².
- •Absence of:
- •Angina symptoms;
排除标准
- •Use of antibiotics within 8 weeks before study enrollment.
- •Heart failure, NYHA functional class ≥ II.
- •Renal insufficiency, defined as creatinine clearance <30 mL/min, calculated using the Cockcroft-Gault equation.
- •Hepatic insufficiency, defined by:
- •Thrombocytopenia;
- •Reduced serum albumin;
- •Prolonged prothrombin time.
- •Inflammatory bowel disease.
- •Obstructive biliary disease.
- •History of digestive tract surgery, including:
- •Cholecystectomy;
- •Gastrectomy;
- •Colectomy.
- •Diabetes mellitus.
- •Use of antidiabetic medications.
- •Hypertriglyceridemia.
- •Use of illicit drugs.
- •Habitual consumption of wine or other alcoholic beverages.
- •Unstable angina.
- •Moderate valvular heart disease.
- •Chagas disease.
- •Permanent pacemaker implantation.
- •Chronic obstructive pulmonary disease (COPD).
- •Aortic aneurysm.
- •Aortic ectasia measuring <40 mm.
研究组 & 干预措施
Red Juice/ Abstention
Group 1(Red Juice/ Abstention) will first consume 400 mL of red grape juice per day, five days per week, for three weeks, followed by a period of abstinence from polyphenol-rich foods.
干预措施: Red Grape Juice (Other)
Abstention/ Red Juice
Group 2 (Abstention/ Red Juice) will follow the same interventions in the opposite order, beginning with the abstinence period and then consuming red grape juice.
干预措施: Red Grape Juice (Other)
结局指标
主要结局
Plasma Metabolomics Changes
时间窗: From enrollment to the end of treatment at 10 weeks
Change in plasma metabolomic profile after red grape juice consumption compared with the abstinence period.
次要结局
未报告次要终点
研究者
Protásio Lemos da Luz
Professor Doctor
InCor Heart Institute