Nutrition and Physical Activity in Patients With Cerebrovascular Disease (ALVINA)
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ClinicalTrials.gov Identifier: NCT01146132 |
Recruitment Status
:
Completed
First Posted
: June 17, 2010
Last Update Posted
: October 5, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebrovascular Disorders | Dietary Supplement: Conventional diet +/- wine Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 119 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Official Title: | Nutrition and Physical Activity in Patients With Cerebrovascular Disease |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |
Arm | Intervention/treatment |
---|---|
Luxembourg diet + wine
Luxembourg variant of the mediterranean Diet, physical activity with wine consumption
|
Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine
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"
|
conventional + wine
conventional Diet with red wine
|
Dietary Supplement: Conventional diet +/- wine
usual eating habits
|
conventional
conventional diet without wine
|
Dietary Supplement: Conventional diet +/- wine
usual eating habits
|
Luxembourg diet
Luxembourg variant of the mediterranean Diet, physical activity with wine consumption
|
Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine
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"
|
- Differences in mean systolic blood pressure in the two diet/sport arms [ Time Frame: 4 months ]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 ]Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.
- Assessment of genetic marker and/or genetic modifications. [ Time Frame: Baseline ]
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

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Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146132
Luxembourg | |
CHL | |
Luxembourg, Luxembourg, 1210 |
Principal Investigator: | Dirk Droste, Pr, MD | Centre Hospitalier du Luxembourg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Manon Gantenbein, Clinical Research Coordinator, Public Research Centre Health, Luxembourg |
ClinicalTrials.gov Identifier: | NCT01146132 History of Changes |
Other Study ID Numbers: |
CRP-Santé |
First Posted: | June 17, 2010 Key Record Dates |
Last Update Posted: | October 5, 2012 |
Last Verified: | October 2012 |
Keywords provided by Manon Gantenbein, Public Research Centre Health, Luxembourg:
Nutrition Physical activity Cerebrovascular disease wine consumption |
BMI Pulse transit time transcranial Doppler sonography |
Additional relevant MeSH terms:
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |