NCT00954434

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

August 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

August 6, 2009

Last Update Submit

May 16, 2016

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • effects on laboratory variables, mood and body composition

    changes in mood, blood lipids, insulin levels, markers of inflammation and effects on liver and body composition.

    3 months

Secondary Outcomes (1)

  • effects on liver fat amount

    3 months

Study Arms (2)

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

total abstention from alcohol

NO INTERVENTION

Interventions

red wineDIETARY_SUPPLEMENT

intake of red wine on a daily basis

red wine

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects
  • years of age and older

You may not qualify if:

  • alcoholic first degree relatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Fredrik H Nystrom, MD PhD prof

    University Hospital of Linkoping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 7, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 17, 2016

Record last verified: 2016-05