The Effect of Alcohol on ABCA1 Expression and Lipid Metab... | NCT00558935

Studies
The Effect of Alcohol on ABCA1 Expression and Lipid Metabolism

NCT00558935

Sponsor

Bayside Health

Status

Terminated

Last Update Posted

May 10, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes
Heart Disease

Interventions

Red Wine

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It was found that 20g of alcohol daily had no effect on ABCA1 expression or HDL levels.

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Nov 14, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2011

Last Update Posted Date

May 10, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Red Wine	Dietary Supplement	20g alcohol daily/red wine for 4 weeks

Measure	Description	Time Frame
measurements of dyslipidemia		2 years

Measure	Description	Time Frame
lipid functionality		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bronwyn A Kingwell, PhD	Baker Heart Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baker Heart Research Institute		Melbourne	Victoria	3004	Australia

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D006331	Heart Diseases

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided