Clinical trial NCT01146132: Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Official title: Nutrition and Physical Activity in Patients With Cerebrovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disorders
Keywords: Nutrition
Physical activity
Cerebrovascular disease
wine consumption
BMI
Pulse transit time
transcranial Doppler sonography
Lead sponsor: Public Research Centre Health, Luxembourg
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier du Luxembourg
First posted: 2010-06-17
Enrollment: 119
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Differences in mean systolic blood pressure in the two diet/sport arms
timeFrame: 4 months
Secondary outcomes:
measure: Effects on cerebrovascular health profile
timeFrame: 4 months
measure: Assessment of genetic marker and/or genetic modifications.
timeFrame: Baseline
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: CHL
Study officials:
affiliation: Centre Hospitalier du Luxembourg
name: Dirk Droste, Pr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.