The Effects of a Mediterranean Style Diet in Heart Disease Patients Running a Cardiac Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in SMART Risk Score
研究概览
简要总结
Nutrition is capable of altering the cardiovascular health of the general population. However, the ideal food and nutritional interventions for the secondary prevention of cardiovascular brain disease and for cardiac rehabilitation are still far from being defined, given the lack of scientific evidence in this specific population of individuals with atherosclerotic disease. This work aims to demonstrate that an intensive program will improve cardiovascular risk predictor parameters, such as high systolic blood pressure, altered lipid and glucose profile, used in the SMART Risk Score tool. In this 12-week clinical study with two arms running in parallel, individuals referred to a cardiac rehabilitation program will receive either an intensive food and nutrition intervention program with nutrition consultations, in which the adoption of the Mediterranean diet is promoted, with contacts telephone calls, short text messages, consultation support tools, podcasts, free access short videos, culinary medicine sessions and nutrition "workshops", or the standard of care program recommended in the Nutritional Support Protocol of the Cardiac Rehabilitation Program. At the beginning of the study, at 4 weeks, at 8 weeks and at 12 weeks, blood and urine samples will be collected, body composition, blood pressure, adherence to the Mediterranean dietary pattern will be assessed, by applying the PREDIMED questionnaire and the dietary intake of 24h previous. The quality of life of individuals will be assessed by the EQ-5D-5L questionnaire at the beginning and at the end of the study. It is expected that the increased intensity and support from the intensive program will have a significant impact on the various metabolic and inflammatory markers predictive of cardiovascular risk and that these observed changes will result in a decreased 10-year risk of developing acute myocardial infarction, stroke or vascular death. On the other hand, the intervention is intended to improve quality of life, improve weight control and assess the impact it has on adherence to the Mediterranean dietary pattern.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with ST-segment elevation acute myocardial infarction undergoing primary angioplasty;
- •Ages 30-90 years;
- •Willing and able to provide written informed consent.
排除标准
- •Subjects with heart failure (LVEF <40%) on admission;
- •Subjects with renal failure (GFR <50 ml / min / 1.73m²);
- •Subjects requiring internment;
- •Subjects who present any other condition that may interfere with adherence to the study protocol.
- •Subjects who attract to be accompanied by another nutritionist;
- •Subjects who have a specific dietary pattern or who take vitamin and/or mineral supplements;
- •Subjects unable to give consent.
研究组 & 干预措施
Mediterranean style diet
Mediterranean style diet.
干预措施: Mediterranean style diet (Behavioral)
Standard of care
Standard of care.
干预措施: Standard of care (Behavioral)
结局指标
主要结局
Change in SMART Risk Score
时间窗: baseline to 12 weeks
Difference between the intervention and control group in the change in SMART Risk Score from baseline to the end of follow-up.
次要结局
- Change in total body water(baseline to 12 weeks)
- Change of type 1 insulin-like growth factor (IGF-1)(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of triglycerides(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of apolipoprotein A1(baseline, 4 weeks, 8 weeks and 12 weeks)
- Adherence to the Mediterranean dietary pattern(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change in fat free mass(baseline to 12 weeks)
- Self-reported quality of life(baseline to 12 weeks)
- Change in weight(baseline to 12 weeks)
- Change in body fat(baseline to 12 weeks)
- Change in diastolic blood pressure(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of interleukin 1(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of trimethylamine N-oxide (TMAO)(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change in systolic blood pressure(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of insulin(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of fasting blood glucose(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of glycosylated hemoglobin (HbA1c)(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of LDL cholesterol(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of HDL cholesterol(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of apolipoprotein B(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of interleukin 6(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of tumor necrosis factor alpha (TNF-α)(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of plasma proportion of alpha linolenic acid(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of liporprotein(a)(baseline, 4 weeks, 8 weeks and 12 weeks)
- change of myeloperoxidase(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of high sensitivity C-reactive protein(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of L-carnitine(baseline, 4 weeks, 8 weeks and 12 weeks)
- Change of urinary hydroxytyrosol(baseline, 4 weeks, 8 weeks and 12 weeks)