Nutrition and Physical Activity in Patients With Cerebrovascular Disease (ALVINA)

• Differences in mean systolic blood pressure in the two diet/sport arms [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  Assess the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition and on surrogate parameters for cerebrovascular disease.
  
  

• Effects on cerebrovascular health profile [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.
  
  
• Assessment of genetic marker and/or genetic modifications. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

  The genetic analyses will investigate:

  A) Profiles of inflammatory, anti-inflammatory cytokines B) Genes related to risk of stroke C) Chromosome regions related to atherosclerosis D) Genetic polymorphism in inflammation

  Genes to be analyzed: FABP2, MTP1, ApoE, ApoA1, PPAR gamma Pro 12 Ala, TNF alpha, Paraoxonase 1, ADH, Kinesin-like protein (KIF) 6 Trp719Arg (rs20455), SNP, 5 (component of complement 5) 2416A> G variant (rs17611), sCAMs (sICAM-1, sVCAM-1, sPSEL et sESEL), (C3, C4) Complement and CRP, P-selectin and its ligand, P-selectin glycoprotein ligand 1

  
  

Quality of life in the elderly and their families is severely affected by stroke and cognitive dysfunction caused by atherosclerosis of the brain supplying arteries. Nutrition, namely a Mediterranean-style diet, nuts, soybean products, whole grain products, dark chocolate, fish oil and avoidance of salt, and regular physical activity play a major role in the prevention of these diseases. Data are available on cardiac patients, however little is known on cerebrovascular patients. The role of red wine in the protection of cerebrovascular disease is discussed; it may be simply an epiphenomenon of otherwise healthy lifestyle in the population with a regularly low alcohol consumption not properly corrected for in epidemiological studies. No prospective randomised data is available.

We intend to perform a prospective randomised study on nutrition and physical activity in 100 patients with chronic cerebrovascular disease (i.e. patients with atherosclerotic stenosis, at least 20% of a brain supplying artery as demonstrated by carotid ultrasound and without an acute stroke/TIA). The study consists of three parts:

(1) Assessment of eating and physical activity habits in these patients and correlation with indicators of cerebrocardiovascular disease (cerebral perfusion as measured by transcranial Doppler sonography, pulsatility of the transcranial and extracranial Doppler signal, elasticity of the carotid artery, ankle-brachial index, cognitive functioning) and risk factors of cerebrovascular disease (blood pressure and blood pressure amplitude assessed by 24 h ambulatory blood pressure measurement; HDL, LDL, triglycerides, Lp(a), glucose, HbA1c, homocysteine, and fibrinogen; waist-hip ratio and BMI).

2) Half of these patients will be randomised to intensive counselling concerning healthy eating and physical activity habits during the first month once a week. All the 100 patients will be reassessed after one month and after 4 months with the above mentioned parameters.

3) In a double cross-over design half of the patients allocated to intensive counselling (i.e. n=25) and half of the patients without intensive counselling (n=25) will be allocated to 0,2 l of red wine daily (men) or 0,1l of red wine daily (women), respectively. The remaining 50 patients will be advised to avoid red wine for the time of the study.