Effects of Red Wine on Cardiovascular Risk Factors in Humans

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00954434
First received: August 6, 2009
Last updated: March 28, 2011
Last verified: August 2009
  Purpose

Fifty healthy human subjects are randomized to not to consume any alcohol at all or to drink 1 glass of red wine/day for women or 2 glasses for men for three months. Outcomes are changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.


Condition Intervention Phase
Healthy Subjects
Dietary Supplement: red wine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • effects on laboratory variables, mood and body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.


Secondary Outcome Measures:
  • effects on liver fat amount [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: red wine
intervention: dietary supplement intake of red wine on a daily basis, 1 glass/day for women, 2 for men
Dietary Supplement: red wine
intake of red wine on a daily basis
No Intervention: total abstention from alcohol Dietary Supplement: red wine
intake of red wine on a daily basis

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects
  • 25 years of age and older

Exclusion Criteria:

  • alcoholic first degree relatives
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00954434

Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Fredrik H Nystrom, MD PhD prof University Hospital of Linkoping, Sweden
  More Information

No publications provided

Responsible Party: Fredrik H Nystrom MD, professor, University Hospital, Linkoeping, Sweden
ClinicalTrials.gov Identifier: NCT00954434     History of Changes
Other Study ID Numbers: M246-08
Study First Received: August 6, 2009
Last Updated: March 28, 2011
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on July 22, 2014