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Effects of Red Wine on Cardiovascular Risk Factors in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00954434
First Posted: August 7, 2009
Last Update Posted: May 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Linkoeping
  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: None (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 ]
    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 ]

Enrollment: 44
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects
  • 25 years of age and older

Exclusion Criteria:

  • alcoholic first degree relatives
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954434


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

Responsible Party: Fredrik H Nystrom MD, professor, University Hospital, Linkoeping, Sweden
ClinicalTrials.gov Identifier: NCT00954434     History of Changes
Other Study ID Numbers: M246-08
First Submitted: August 6, 2009
First Posted: August 7, 2009
Last Update Posted: May 17, 2016
Last Verified: May 2016