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Alcohol and Atherosclerosis Pilot Study (AAAPILOT)

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ClinicalTrials.gov Identifier: NCT00786279
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : January 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
We propose a pilot study to determine the feasibility of a long-term clinical trial of alcohol intake on atherosclerosis, the first step in determining whether moderate drinking prevents cardiovascular disease and hence in understanding the full health effects of alcohol across the population. We will randomize 40 participants aged 55 and older to a six-month period of consumption of 1 glass per day of either pure alcohol (diluted to the strength of wine) or water. At baseline and after 6 months, we will measure several standard and novel cardiovascular risk markers in the blood and will perform magnetic resonance imaging to measure atherosclerosis of the aorta.

Condition or disease Intervention/treatment
Atherosclerosis Other: ethanol Other: Ethanol-free beverage

Detailed Description:

The feasibility of a long-term randomized trial of alcohol intake on clinical endpoints is uncertain. One approach that could minimize the size and duration of such a randomized trial would be to assess the effect of alcohol on progression of radiologically-defined atherosclerosis.

We propose a proof-of-principle pilot study of the effect of longer-term alcohol intake on atherosclerosis. We will recruit and randomize 40 participants aged 55 and older at high risk for CHD to a six-month period of consumption of a single 150 ml glass per day of either 10% ethanol (approximating wine) or water. At baseline and after 6 months, we will assess aortic atherosclerosis using magnetic resonance imaging. We will determine adherence in several ways, including serum markers, dietary recalls, and measurement of unused beverage. The primary outcomes in this feasibility study will be compliance with alcohol intake and the two MRI examinations. As secondary outcomes, we will measure standard and novel cardiovascular risk markers, including inflammatory markers and measures of glucose metabolism. We will assess safety on a continual basis, including repeated testing of liver enzymes and blood counts.

If successful, this pilot study will form the basis for a more definitive trial to determine the effect of alcohol intake on progression of atherosclerosis, which could itself establish the feasibility of even larger, longer-term studies of alcohol intake and occurrence of cardiovascular events.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Alcohol and Atherosclerosis Pilot Study
Study Start Date : November 2008
Primary Completion Date : March 2011
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
150 cc daily of flavored, calorie-free beverage without alcohol
Other: Ethanol-free beverage
0 grams ethanol daily for 6 months.
Experimental: 2
150 cc flavored, calorie-free beverage with 15 gm ethanol daily
Other: ethanol
15 gm ethanol daily for 6 months

Outcome Measures

Primary Outcome Measures :
  1. Adherence to alcohol intake and MRI examinations [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. GGT [ Time Frame: Monthly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diabetes
  • Current Smoking
  • Hypertension
  • Family history of heart disease
  • High LDL Cholesterol (>130 mg/dl)
  • Low HDL CHolesterol (<40 mg/dl)
  • Body Mass Index of 30 kg/m^2
  • Waist circumference greater than 40 inches for men and 35 inches for women
  • Report intake of at least one drink in the last month
  • Post-menopause (if woman)

Exclusion Criteria:

  • History of myocardial infarction (MI)/ heart attack within prior 6 months.
  • Revascularization procedure (coronary, carotid, or peripheral)
  • Stroke
  • Claustrophobia
  • Intolerance to previous MRI examinations
  • Standard MRI contraindications (e.g. pacemaker, intra-auricular implants, or intracranial clips)
  • Weight over 350 pounds
  • Active atrial fibrillation
  • Reports intake of more than 7 drinks per week currently, has previous or current history of alcohol abuse based on standard questionnaires, or who has consumed more than 4 drinks in one day within the last 6 months.
  • Intolerance or allergy to alcohol consumption (includes flushing)
  • Allergy to aspartame, acesulfame, or artificial food coloring
  • Any severe illness expected to cause death or profound disability within 6 months
  • Evidence of depression (as measured based on a Center for Epidemiological Studies Depression score of 16 or higher)
  • History of chronic liver disease
  • Personal history of breast or any gastrointestinal cancer, uncontrolled hypertension (blood pressure greater than or equal to 180/110)
  • Chronic renal failure on dialysis
  • Current use of Metronidazole or Warfarin
  • Use of benzodiazepines, barbiturates, and related sedative/ hypnotics 4 or more days per week.
  • Severe psychiatric illness
  • Inability to speak English
  • Lack of a working telephone
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00786279

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Kenneth J. Mukamal, MD, MPH Beth Israel Deaconess Medical Center
More Information

Responsible Party: Kenneth Mukamal, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00786279     History of Changes
Obsolete Identifiers: NCT01377727
Other Study ID Numbers: 2008P-000164 AAAPILOT
R21AA016110 ( U.S. NIH Grant/Contract )
1R21AA016110 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Kenneth Mukamal, Beth Israel Deaconess Medical Center:

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs