Nutrition and Physical Activity in Patients With Cerebrovascular Disease

Study Overview
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Brief Summary
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The study will provide evidence of eating habits and physical activity in cerebrovascular patients in Luxembourg and of the degree to which these habits may be changed acutely (after one month) and in the long run (after 4 months) by intensive counselling. Furthermore the influence of intensive counselling and of the consumption of red wine on cerebrovascular risk factors, cognition, and on surrogate parameters for stroke will be assessed.

Detailed Description
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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.

Official Title
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Nutrition and Physical Activity in Patients With Cerebrovascular Disease

Conditions
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Cerebrovascular Disorders

Intervention / Treatment
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* Dietary Supplement: Conventional diet +/- wine
* Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In- and outpatients of the Neurology Department of the CHL and their family members Carotid atherosclerosis assessed by B-mode ultrasound of at least 20% lumen reduction No acute stroke/TIA/amaurosis fugax (at least 3 months ago) Temporal ultrasound window suitable for recording of the middle cerebral artery Ability to give informed consent Exclusion Criteria: No signed informed consent patient not able to give informed consent

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Luxembourg diet + wine<br>Luxembourg variant of the mediterranean Diet, physical activity with wine consumption | Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine<br>* Walnuts, almonds, mustard and soy bean products as part of the Indo-Mediterranean diet could be recommended to ensure a variety of food constellation, as well as dark chocolate. This form of diet will be addressed to as Luxembourg variant of the Mediterranean diet<br>|
| Other: conventional + wine<br>conventional Diet with red wine | Dietary Supplement: Conventional diet +/- wine<br>* usual eating habits<br>|
| Other: conventional<br>conventional diet without wine | Dietary Supplement: Conventional diet +/- wine<br>* usual eating habits<br>|
| Other: Luxembourg diet<br>Luxembourg variant of the mediterranean Diet, physical activity with wine consumption | Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine<br>* Walnuts, almonds, mustard and soy bean products as part of the Indo-Mediterranean diet could be recommended to ensure a variety of food constellation, as well as dark chocolate. This form of diet will be addressed to as Luxembourg variant of the Mediterranean diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in mean systolic blood pressure in the two diet/sport arms | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on cerebrovascular health profile | Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters. | 4 months | 
| Assessment of genetic marker and/or genetic modifications. | 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 | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Physical activity, Cerebrovascular disease, wine consumption, BMI, Pulse transit time, transcranial Doppler sonography