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

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier du Luxembourg
Information provided by (Responsible Party):
Manon Gantenbein, Public Research Centre Health, Luxembourg
ClinicalTrials.gov Identifier:
NCT01146132
First received: June 15, 2010
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Nutrition and Physical Activity in Patients With Cerebrovascular Disease

Further study details as provided by Public Research Centre Health, Luxembourg:

Primary Outcome Measures:
  • Differences in mean systolic blood pressure in the two diet/sport arms [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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:
  • Effects on cerebrovascular health profile [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.

  • Assessment of genetic marker and/or genetic modifications. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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



Enrollment: 119
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146132

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

No publications provided by Public Research Centre Health, Luxembourg

Additional 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
Study First Received: June 15, 2010
Last Updated: October 4, 2012
Health Authority: Luxembourg: Comite National d'Ethique de Recherche

Keywords provided by 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

ClinicalTrials.gov processed this record on September 22, 2014