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The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism

Primary Purpose

Type 2 Diabetes, Heart Disease

Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Red Wine
Sponsored by
Bayside Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Baker Heart Research Institute

Outcomes

Primary Outcome Measures

measurements of dyslipidemia

Secondary Outcome Measures

lipid functionality

Full Information

First Posted
November 14, 2007
Last Updated
May 9, 2011
Sponsor
Bayside Health
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1. Study Identification

Unique Protocol Identification Number
NCT00558935
Brief Title
The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
It was found that 20g of alcohol daily had no effect on ABCA1 expression or HDL levels.
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayside Health

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Heart Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Red Wine
Intervention Description
20g alcohol daily/red wine for 4 weeks
Primary Outcome Measure Information:
Title
measurements of dyslipidemia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
lipid functionality
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy participants Aged 18-65 years Free of overt coronary disease BMI < 35 Fasting plasma glucose <6.1 mmol Unmedicated No major illness Exclusion Criteria: Unable to give informed consent Smokers Participants with alcoholism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bronwyn A Kingwell, PhD
Organizational Affiliation
Baker Heart Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baker Heart Research Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

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The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism

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