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Moderate Alcohol Consumption, Risk of Cardiovascular Disease and Type 2 Diabetes: Influence of Alcohol Oxidation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285909
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : August 16, 2006
Information provided by:

Brief Summary:

Moderate alcohol consumption is associated with a decreased risk of cardiovascular disease and type 2 diabetes. The association of alcohol consumption with cardiovascular disease is mediated by a functional polymorphism of alcohol dehydrogenase 1c, but the effect of this polymorphism on alcohol metabolism is only investigated in vitro.

The risk reduction of moderate alcohol consumption for cardiovascular disease is explained largely by an increase of HDL cholesterol, but an increase of adiponectin concentrations after moderate alcohol consumption may also be involved. It seems likely that adiponectin is a mediator for the association of moderate alcohol consumption with type 2 diabetes. The mechanism by which moderate alcohol consumption increases adiponectin concentrations is unknown, but ppar-gamma activation may be involved.

effects of this polymorphism on mediators of this relation are not known. This study therefore investigates the effect of moderate alcohol consumption and the influence of alcohol dehydrogenase 1c polymorphism on ppar-gamma activated gene expression and risk factors of cardiovascular disease and type 2 diabetes.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Type 2 Diabetes Behavioral: Alcohol: 25 gday (white wine) Not Applicable

Detailed Description:

Objectives :

To investigate the effect of moderate alcohol consumption and influence of genetic variation of ethanol oxidation on:

  • PPAR-γ activated gene expression
  • Markers of coronary heart disease or type 2 diabetes
  • Postprandial changes of HPA-axis activity among 36 postmenopausal women with ADH1C genotype associated with slow or fast alcohol metabolism.

Design : Randomized, controlled, not blinded crossover trial with 1 week wash-out preceding each treatment period


  • Description : Apparently healthy postmenopausal women
  • Number : 36

Study substances

  • Test substance : White wine (ca. 25 g alcohol/day)
  • Reference substance : White grape juice

Study treatments Treatment A: 250 ml white wine daily (ca. 25 g alcohol/day) Treatment B: 250 ml white grape juice daily

Study period

- Duration : two periods of 6 weeks preceded by 1 week wash-out period

Test parameters:

  • Adiponectin mRNA expression
  • Expression of PPAR-gamma activated genes: CD36, lipoprotein lipase, AP2
  • Markers of cardiovascular disease (blood lipid profile, Lp-PLA2 activity, hs-CRP, fibrinogen)
  • Markers of type 2 diabetes (adiponectin, adiponectin oligomers, insulin sensitivity)
  • Parameters of alcohol oxidation (postprandial: blood alcohol and acetate, acetaldehyde)
  • HPA-axis activity (postprandial & fasting: cortisol, ACTH, testosterone)

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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Moderate Alcohol Consumption on PPAR-γ Activity and Risk Markers of Metabolic Disease: Influence of Genetic Variation in Alcohol Oxidation
Study Start Date : March 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Primary Outcome Measures :
  1. PPAR-gamma activated gene expression

Secondary Outcome Measures :
  1. Risk factors of cardiovascular disease and type 2 diabetes
  2. Postprandial changes of HPA-axis activity

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy women aged 40 to 65 years
  • Absence of menstrual period for at least 2 years
  • Homozygotes for the ADH1C*1 or ADH1C*2 allele of ADH1C I349V polymorphism
  • Alcohol consumption ≥ 5 and ≤ 21 units/week

Exclusion Criteria:

  • Smoking
  • Family history of alcoholism
  • History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders
  • Recent blood donation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285909

Sponsors and Collaborators
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Principal Investigator: Henk FJ Hendriks, PhD. TNO
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00285909    
Other Study ID Numbers: P6689
Alcohol research 20
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: August 16, 2006
Last Verified: August 2006
Keywords provided by TNO:
Moderate alcohol consumption
Alcohol dehydrogenase 1c polymorphism
PPAR-gamma activated gene expression
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus, Type 2
Alcohol Drinking
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Drinking Behavior