Effects of Red Wine on Cardiovascular Risk Factors in Humans

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: red wine

• Registration Number: NCT00954434
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Study Start: 2009-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• healthy subjects
• 25 years of age and older

Exclusion Criteria

• alcoholic first degree relatives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
red wine	red wine	intervention: dietary supplement intake of red wine on a daily basis, 1 glass/day for women, 2 for men

Primary Outcome Measures

Name	Time	Method
effects on laboratory variables, mood and body composition	3 months	changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.

Secondary Outcome Measures

Name	Time	Method
effects on liver fat amount	3 months