Randomized, Double-blind, Cross-over Placebo-controlled Study to Assess the Functional Meat Products With n-3 and Rosemary Extract Fluid in Biochemical Markers of Cardiovascular Disease Related Risk in Subjects at Low Risk for Cardiovascular Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Lipid profile changes
研究概览
简要总结
Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods: intervention (I) and control (C) in different order (I/C or C/I). Both periods were separated by a 4 weeks wash-out interval during which subjects returned to their usual diet:
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey breast (FT)), were manufactured mixing the meats with the patented formula® (P200402755.2004). The amount of supercritical rosemary extract, deodorized salmon oil and vitamin E used was respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.
Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were prepared without addition of the functional ingredients.
详细描述
The total duration of the study was 28 weeks: first experimental period 0-12 weeks, washout period 12-16 weeks second experimental period 16-28 weeks:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged over 18 years
- •At least 2 lipid profile parameters altered (TAG ≥150 mg /dl and/or total cholesterol ≥200 mg / dl and/or LDL ≥130 mg / dl and/or HDL ≥40mg/dl men or ≥ 50mg/dl women).
- •Signed informed consent
排除标准
- •Individuals with body mass index (BMI) ≥ 35 kg/m2
- •Individuals with Diabetes Mellitus insulin dependent
- •Individuals with disorders associated with eating behaviour
- •Individuals with consumption of omega 3 functional foods, fish oil or antioxidant supplements
- •Individuals inability to consume the test foods (ej. Vegetarians)
- •Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
- •Individuals with mental disease or low cognitive function.
- •Individuals with consumption of drugs to weight lost.
- •Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
- •Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.).
- •Pregnant women or lactating.
- •Individuals with regular consumption of anti-inflammatory or glucocorticoids.
研究组 & 干预措施
Functional meat
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
干预措施: Functional Meet (Other)
Functional meat
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
干预措施: Control Meat (Other)
Control Meat
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
干预措施: Functional Meet (Other)
Control Meat
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
干预措施: Control Meat (Other)
结局指标
主要结局
Lipid profile changes
时间窗: 0, 12, 16 and 28 week
Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Apolipoprotein B and Apolipoprotein A.
次要结局
- Oxidative Stress Parameters changes(0, 12, 16 and 28 week)
- Anthropometric parameters changes(0, 12, 16 and 28 week)
- Blood pressure and heart rate changes(0, 12, 16 and 28 week)
- Framingham score changes(0, 12, 16 and 28 week)
- Inflammatory markers changes(0, 12, 16 and 28 week)
- Glucosa Metabolism changes(0, 12, 16 and 28 week)