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

Study Description

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Brief Summary:

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.

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

Detailed Description:

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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"

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Effects on cerebrovascular health profile [ Time Frame: 4 months ]
   Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.
2. 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

Luxembourg
CHL
Luxembourg, Luxembourg, 1210

Sponsors and Collaborators

Manon Gantenbein

Centre Hospitalier du Luxembourg

Investigators

Principal Investigator:	Dirk Droste, Pr, MD	Centre Hospitalier du Luxembourg

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Droste DW, Iliescu C, Vaillant M, Gantenbein M, De Bremaeker N, Lieunard C, Velez T, Meyer M, Guth T, Kuemmerle A, Gilson G, Chioti A. A daily glass of red wine associated with lifestyle changes independently improves blood lipids in patients with carotid arteriosclerosis: results from a randomized controlled trial. Nutr J. 2013 Nov 15;12(1):147. doi: 10.1186/1475-2891-12-147.

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
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