NCT01146132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

June 15, 2010

Last Update Submit

October 4, 2012

Conditions

Cerebrovascular Disorders

Keywords

NutritionPhysical activityCerebrovascular diseasewine consumptionBMIPulse transit timetranscranial Doppler sonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Effects on cerebrovascular health profile

    4 months

  • Assessment of genetic marker and/or genetic modifications.

    Baseline

Study Arms (4)

Luxembourg diet + wine

OTHER

Luxembourg variant of the mediterranean Diet, physical activity with wine consumption

Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine

conventional + wine

OTHER

conventional Diet with red wine

Dietary Supplement: Conventional diet +/- wine

conventional

OTHER

conventional diet without wine

Dietary Supplement: Conventional diet +/- wine

Luxembourg diet

OTHER

Luxembourg variant of the mediterranean Diet, physical activity with wine consumption

Dietary Supplement: Luxembourg variant of Mediterranean diet + physical activity +/- wine

Interventions

Conventional diet +/- wineDIETARY_SUPPLEMENT

usual eating habits

conventionalconventional + wine
Luxembourg variant of Mediterranean diet + physical activity +/- wineDIETARY_SUPPLEMENT

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 dietLuxembourg diet + wine

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No signed informed consent
  • patient not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHL

Luxembourg, 1210, Luxembourg

Location

Related Publications (1)

  • 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.

    PMID: 24228901DERIVED

MeSH Terms

Conditions

Cerebrovascular DisordersMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Dirk Droste, Pr, MD

    Centre Hospitalier du Luxembourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 17, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

LU(1)