Nutrition and Physical Activity in Patients With Cerebrovascular Disease

Cerebrovascular Disorders Clinical Trial

— ALVINA  

Official title:

Nutrition and Physical Activity in Patients With Cerebrovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146132
• Other study ID #: CRP-Santé
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: October 4, 2012
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Public Research Centre Health, Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Luxembourg: Comite National d'Ethique de Recherche
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Cerebrovascular Disorders

Intervention

Dietary Supplement:
• Conventional diet +/- wine
usual eating habits
• 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"

Locations

Country	Name	City	State
Luxembourg	CHL	Luxembourg

Sponsors (2)

Lead Sponsor	Collaborator
Manon Gantenbein	Centre Hospitalier du Luxembourg

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Effects on cerebrovascular health profile	Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.	4 months	Yes
Secondary	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	No