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

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ClinicalTrials.gov Identifier: NCT01146132
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : October 5, 2012
Sponsor:
Collaborator:
Centre Hospitalier du Luxembourg
Information provided by (Responsible Party):
Manon Gantenbein, Public Research Centre Health, Luxembourg

Tracking Information
First Submitted Date  ICMJE June 15, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date October 5, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
  • Effects on cerebrovascular health profile [ Time Frame: 4 months ]
    Assess effects on cerebrocardiovascular health profile, cognitive function and ultrasound parameters.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Official Title  ICMJE Nutrition and Physical Activity in Patients With Cerebrovascular Disease
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Condition  ICMJE Cerebrovascular Disorders
Intervention  ICMJE
  • 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"
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2012)
119
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)
100
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Luxembourg
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01146132
Other Study ID Numbers  ICMJE CRP-Santé
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manon Gantenbein, Public Research Centre Health, Luxembourg
Study Sponsor  ICMJE Manon Gantenbein
Collaborators  ICMJE Centre Hospitalier du Luxembourg
Investigators  ICMJE
Principal Investigator: Dirk Droste, Pr, MD Centre Hospitalier du Luxembourg
PRS Account Public Research Centre Health, Luxembourg
Verification Date October 2012

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