Study of the Effect of Ready-cooked Meals Containing Cocoa Extract, as a Potential Functional Ingredient, on Cardiovascular Risk Markers in Older Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline of Plasma Oxidized LDL
研究概览
简要总结
Obesity prevalence in elderly populations has increased in the last years, and the reduction of overweight and obesity is a priority target in populations of all age ranges worldwide. Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic functions may be compromised, and therefore there is a risk of developing comorbidities such as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context, plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols have been shown to have an important antioxidant effect. Scientific evidence based on epidemiological studies suggest that flavonoids from the diet play an important role on the prevention of cardiovascular disease. Cocoa and related products are an important source of flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa consumption are related to the ability for improving lipid profile and insulin sensitivity, reducing blood pressure, platelet activity and improving endothelial dysfunction. Some studies have also shown an improvement of inflammatory conditions, mainly due to the capacity of the polyphenols contained to modify cellular transcription, and the secretion of proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic strains. Therefore, the hypothesis of this study is that the consumption of cocoa extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight and to improve cardiovascular risk factors compared to the same diet with standard prepared meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 27 and 35.5 kg/m2
- •Subjects with central adiposity (waist circumference over 94 cm in males and 80 cm in females)
- •Subjects presenting insulin resistance non pharmacologically treated
- •Subjects presenting hyperlipidemia non pharmacologically treated
排除标准
- •Subjects following dietotherapy to loose weight at the moment of the study or in the past three months.
- •Subjects with variations of weight greater than 5% of their body weight in the last three months).
- •Subjects with deficient nutritional or hydration status.
- •Subjects suffering from chronic diseases such as cancer, diabetes, hyperlipidemia, etc.
- •Subjects with functional or structural impairments in digestive tract (peptic ulcer, malabsorption syndrome, inflammatory state, etc.)
- •Subjects having gone under digestive surgery and have permanent consequences.
- •Subjects suffering from allergy to cocoa or derived products.
- •Subjects being physically or psychologically affected, with difficulties to attend the facilities with the required frequency.
- •Smokers and frequent (more than 3 portions of beer/wine/spirits per day in males and 2 portions of beer/wine/spirits per day in females)
结局指标
主要结局
Change from baseline of Plasma Oxidized LDL
时间窗: Baseline and 4 weeks
Levels of LDL-ox in plasma will be analysed at the beginning and the end (4 weeks) of each intervention period
次要结局
- Change from baseline of fat mass content(Baseline and 4 weeks)
- Change from baseline of waist circumference(Baseline and 4 weeks)
- Change from baseline of hip circumference(Baseline and 4 weeks)
- Height(Baseline)
- Change from baseline of body weight(Baseline and 4 weeks)
- Change from baseline of skinfolds(Baseline and 4 weeks)
- Change from baseline of serum glucose levels(Baseline and 4 weeks)
- Change from baseline of serum insulin concentration(Baseline and 4 weeks)
- Change from baseline of serum free fatty acids concentration(Baseline and 4 weeks)
- Change from baseline of serum total cholesterol concentration(Baseline and 4 weeks)
- Change from baseline of serum HDL-cholesterol concentration(Baseline and 4 weeks)
- Change from baseline of serum LDL-cholesterol concentration(Baseline and 4 weeks)
- Change from baseline of serum triglycerides concentration(Baseline and 4 weeks)
- Change from baseline of serum total protein concentration(Baseline and 4 weeks)
- Change from baseline of serum transaminases concentration(Baseline and 4 weeks)
- Change from baseline of serum homocystein concentration(Baseline and 4 weeks)
- Change from baseline of Diastolic blood pressure(Baseline and 4 weeks)
- Change from baseline of Systolic blood pressure(Baseline and 4 weeks)
- Change from baseline of Food intake(Baseline and 4 weeks)
- Change from baseline of plasma PAI-1 concentration(Baseline and 4 weeks)
- Change from baseline of plasma malonyldialdehyde (MDA) concentration(Baseline and 4 weeks)
- Change from baseline of plasma total antioxidant capacity (TAC)(Baseline and 4 weeks)
- Change from baseline of serum uric acid levels(Baseline and 4 weeks)
- Change from baseline of Glutathione peroxidase activity(Baseline and 4 weeks)
- Change from baseline of plasma C-Reactive Protein levels(Baseline and 4 weeks)
- Change from baseline of plasma IL-6 levels(Baseline and 4 weeks)
- Change from baseline of plasma TNF-alpha levels(Baseline and 4 weeks)
- Personality Test(Baseline)
- Change from baseline of depression degree(Baseline and 4 weeks)
- Change from baseline of health status(Baseline and 4 weeks)
- Change from baseline of plasma VCAM-1 levels(Baseline and 4 weeks)
- Change from baseline of plasma ICAM-1 levels(Baseline and 4 weeks)
- Cocoa Bioavailability(Baseline and 4 weeks)
- DNA damage(Baseline and 4 weeks)
研究者
Alfredo Martinez
Professor of Nutrition and Bromatology
Clinica Universidad de Navarra, Universidad de Navarra