NCT00558935

Brief Summary

The purpose of this study is to investigate the effects of red wine on ABCA1 levels

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

November 14, 2007

Last Update Submit

May 9, 2011

Conditions

Type 2 DiabetesHeart Disease

Outcome Measures

Primary Outcomes (1)

  • measurements of dyslipidemia

    2 years

Secondary Outcomes (1)

  • lipid functionality

    2 years

Interventions

Red WineDIETARY_SUPPLEMENT

20g alcohol daily/red wine for 4 weeks

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy participants
  • Aged 18-65 years
  • Free of overt coronary disease
  • BMI \< 35
  • Fasting plasma glucose \<6.1 mmol
  • Unmedicated
  • No major illness

You may not qualify if:

  • Unable to give informed consent
  • Smokers
  • Participants with alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baker Heart Research Institute

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Study Officials

  • Bronwyn A Kingwell, PhD

    Baker Heart Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 16, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations

AU(1)