Alcohol and Atherosclerosis Pilot Study (AAAPILOT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Beth Israel Deaconess Medical Center Identifier:
First received: June 13, 2011
Last updated: June 20, 2011
Last verified: June 2011
The investigators 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. The investigators 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, the investigators 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 Intervention
Other: Ethanol-free beverage
Other: Ethanol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alcohol and Atherosclerosis Pilot Study

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Adherence to alcohol intake and MRI examinations [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GGT [ Time Frame: Monthly over the course of six months ] [ Designated as safety issue: Yes ]
    We will be examining Gamma-glutamyltransferase blood test results.

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Experimental
150 cc flavored, calorie-free beverage with 15 gm ethanol daily
Other: Ethanol
15 gm ethanol daily for 6 months
Placebo Comparator: Placebo Comparator
150 cc daily of flavored, calorie-free beverage without alcohol
Other: Ethanol-free beverage
0 grams ethanol daily for 6 months

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.

The investigators propose a proof-of-principle pilot study of the effect of longer-term alcohol intake on atherosclerosis. The investigators 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, the investigators will assess aortic atherosclerosis using magnetic resonance imaging. The investigators 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, the investigators will measure standard and novel cardiovascular risk markers, including inflammatory markers and measures of glucose metabolism. The investigators 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.


Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Diabetes
  • Current Smoking
  • Hypertension
  • Family history of heart disease
  • History of heart disease, myocardial infarction (MI)/heart attack and/or stroke more than 6 months prior to enrollment
  • 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/stroke within 6 months of enrollment
  • Revascularization procedure (coronary, carotid, or peripheral) within 6 months of enrollment
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01377727

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 Mukamal, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Kenneth J. Mukamal, MD, MPH, Beth Israel Deaconess Medical Center Identifier: NCT01377727     History of Changes
Other Study ID Numbers: 2008P-000164
Study First Received: June 13, 2011
Last Updated: June 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Infective Agents
Central Nervous System Depressants
Anti-Infective Agents, Local
Central Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015