Effects of Red Wine on Cardiovascular Risk Factors in Humans

This study is enrolling participants by invitation only.

First Received: August 6, 2009 No Changes Posted

Sponsored by:	University Hospital, Linkoeping
Information provided by:	University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT00954434

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
No Conditions Healthy Subjects	Dietary Supplement: red wine	Phase I Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Parallel Assignment

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

see description, effects on laboratory variables, mood and body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
red wine: Experimental 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
total abstention from alcohol: No Intervention	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

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

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 11, 2009