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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

June 15, 2010
October 4, 2012
June 2009
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01146132 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Nutrition and Physical Activity in Patients With Cerebrovascular Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Cerebrovascular Disorders
  • Dietary Supplement: Conventional diet +/- wine
    usual eating habits
  • 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"
  • Luxembourg diet + wine
    Luxembourg variant of the mediterranean Diet, physical activity with wine consumption
    Intervention: Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine
  • conventional + wine
    conventional Diet with red wine
    Intervention: Dietary Supplement: Conventional diet +/- wine
  • conventional
    conventional diet without wine
    Intervention: Dietary Supplement: Conventional diet +/- wine
  • Luxembourg diet
    Luxembourg variant of the mediterranean Diet, physical activity with wine consumption
    Intervention: Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Luxembourg
 
NCT01146132
CRP-Santé
No
Manon Gantenbein, Public Research Centre Health, Luxembourg
Manon Gantenbein
Centre Hospitalier du Luxembourg
Principal Investigator: Dirk Droste, Pr, MD Centre Hospitalier du Luxembourg
Public Research Centre Health, Luxembourg
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP