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

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.

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Disorders
• Intervention / Treatment: Dietary supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine; Dietary supplement: Conventional diet +/- wine

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • CHL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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"
OTHER: conventional + wine; conventional Diet with red wine	Dietary supplement: Conventional diet +/- wine; usual eating habits
OTHER: conventional; conventional diet without wine	Dietary supplement: Conventional diet +/- wine; usual eating habits
OTHER: 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"

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Manon Gantenbein
• Collaborators: Centre Hospitalier du Luxembourg
• Investigators: Principal Investigator: Dirk Droste, Pr, MD, Centre Hospitalier du Luxembourg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: June 15, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (ESTIMATE): June 17, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Nutrition; Physical activity; Cerebrovascular disease; BMI; Pulse transit time; wine consumption; transcranial Doppler sonography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: CRP-Santé