Effect of Enriched QUARTET® Hen Eggs on Cardiovascular Function in Cardiovascular Patients and Healthy Individuals
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- T helper lymphocyte differentiation
研究概览
简要总结
Role of oxidative stress in the development of cardiovascular diseases is well known and extensively investigated, because of its direct effects on vascular function, but also on the activation of the immune response. Thus, food products that could increase the antioxidant capacity of the vascular system would also act protective against cardiovascular diseases. However, we lack systematic clinical and pre-clinical research with food products instead of food supplements, which would result in consistent and repeatable results. Many studies have proven the effectiveness of n-3 polyunsaturated fatty acids (n-3 PUFA) in improvement of endothelial function, improvement of elasticity of the vascular wall and the anti-inflammatory effects in patients with chronic diseases, such as metabolic syndrome, if they are taken as an pharmacological preparation. Our research group recently reported that favorable anti-inflammatory properties of n-3 PUFA enriched hen eggs potentially contribute to the improvement of microvascular endothelium-dependent vasodilation in healthy individuals. In addition, this study aimed to determine the effect of QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein; QUARTET No. 012743696, 2014.) consumption on cardiovascular function in both healthy individuals and cardiovascular patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers (sedentary)
- •healthy volunteers (athletes)
- •cardiac patients (patients with acute myocardial infarction, hypertensive patients with/without hypertensive heart disease, heart failure patients)
排除标准
- •for Healthy Volunteers:
- •oral contraceptives
- •drugs that could affect endothelium
- •hypertension
- •coronary artery disease
- •hyperlipidaemia
- •renal impairment
- •cerebrovascular and peripheral artery disease
- •Exclusion Criteria for Cardiac Patients:
- •known malignant disease
- •hereditary metabolic diseases and other hereditary systemic diseases
- •autoimmune diseases or systemic diseases with immunopathology
- •unregulated hypertension
- •recent surgery (3 months)
- •recent significant trauma (6 months)
- •renal insufficiency (except in diabetic patients unless Endogenous Creatinine Clearance > 60ml / min)
- •active bleeding (hematuria, GI tract, menorrhagia)
- •fresh ICV (6 weeks)
- •neurodegenerative diseases and epilepsy
- •significant anemia (Hg <110 (men), <100 (women))
- •condition after resuscitation (3 months)
- •therapy that significantly affects vascular or immune function (monoclonal antibodies, immunosuppressants, systemic corticosteroids ...)
- •chronic respiratory failure and conditions of chronic hypoxemia
- •sepsis and chronic active infections with systemic inflammatory response (active tuberculosis, etc.)
- •untreated thyroid disease
- •active abuse of alcohol and drugs
- •liver failure (advanced liver disease with impaired synthetic and metabolic function)
研究组 & 干预措施
QUARTET®
Consumption of three QUARTET® (n-3 PUFA, selenium, vitamin E, lutein enriched) hen eggs per day for three weeks
干预措施: QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) (Dietary Supplement)
Control
Consumption of three regular hen eggs per day for three weeks
干预措施: Regular hen eggs (Dietary Supplement)
结局指标
主要结局
T helper lymphocyte differentiation
时间窗: 3 weeks
Regulatory T cells (Treg, Foxp3) and Th17 cells will be determined measuring intracellular expression for distinct Th17 markers by using FACS Canto II flow cytometer system.
Endothelial cell activation
时间窗: 3 weeks
Measurement of serum protein concentration of cell adhesion molecules (e.g. intercellular adhesion molecule 1 - ICAM-1, vascular cell adhesion protein 1 - VCAM-1, and E-selectin) by commercially available ELISA kits, or by multiplex assay kits for the Luminex platform (Luminex® 100/200™ System).
Microvascular reactivity
时间窗: 3 weeks
Forearm skin microvascular reactivity in response to: vascular occlusion (post-occlusion reactive hyperemia, PORH); iontophoresis of acetylcholine (endothelium-dependent) and sodium nitroprusside (endothelium-independent); and local thermal hyperemia (LTH, NO-dependent vasodilation), measured by laser Doppler flowmetry (LDF)
Macrovascular reactivity - FMD of brachial artery
时间窗: 3 weeks
Flow mediated dilation (FMD) of brachial artery measured by ultrasound.
Macrovascular reactivity - TCD of cerebral blood vessels
时间窗: 3 weeks
Vascular reactivity of cerebral blood vessels measured by transcranial Doppler (TCD).
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
时间窗: 3 weeks
Measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.
Oxidative stress - antioxidative enzymes
时间窗: 3 weeks
Measurement of biomarkers of oxidative stress level. Plasma concentration of antioxidative enzymes.
Oxidative stress - ferric-reducing ability of plasma (FRAP)
时间窗: 3 weeks
Measurement of biomarkers of oxidative stress level. Ferric-reducing ability of plasma (FRAP) - biomarker of plasma antioxidant capacity.
Serum Pro- and Anti-Inflammatory Cytokines, Chemokines, Growth Factors and Soluble Cell Adhesion Molecules Protein Concentration
时间窗: 3 weeks
Measurement of serum protein concentration (pg/mL) of various pro- and anti-inflammatory cytokines, chemokines, growth factors and soluble cell adhesion molecules by kits and panels for multiplex protein quantitation using the Luminex 200 instrument platform.
次要结局
- Blood pressure(3 weeks)
- Serum lipid profile(3 weeks)
- Body composition(3 weeks)
- Body fluid status(3 weeks)
研究者
Ines Drenjancevic
Head of Scientific center of excellence for personalized health care
Josip Juraj Strossmayer University of Osijek