Alcohol and Atherosclerosis Pilot Study

NCT ID: NCT00786279

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

1

150 cc daily of flavored, calorie-free beverage without alcohol

Group Type: PLACEBO_COMPARATOR

Ethanol-free beverage

Intervention Type: OTHER

0 grams ethanol daily for 6 months.

2

150 cc flavored, calorie-free beverage with 15 gm ethanol daily

Group Type: EXPERIMENTAL

ethanol

Intervention Type: OTHER

15 gm ethanol daily for 6 months

Interventions

ethanol

15 gm ethanol daily for 6 months

Intervention Type: OTHER

Ethanol-free beverage

0 grams ethanol daily for 6 months.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Mukamal

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth J. Mukamal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Panagiotou G, Mu L, Na B, Mukamal KJ, Mantzoros CS. Circulating irisin, omentin-1, and lipoprotein subparticles in adults at higher cardiovascular risk. Metabolism. 2014 Oct;63(10):1265-71. doi: 10.1016/j.metabol.2014.06.001. Epub 2014 Jun 9.

Reference Type: RESULT

PMID: 25060690 (View on PubMed)

Mukamal KJ, Na B, Mu L, Mantzoros CS, Manning WJ, Mittleman MA. Lessons and Challenges from a 6-Month Randomized Pilot Study of Daily Ethanol Consumption: Research Methodology and Study Design. Curr Dev Nutr. 2017 Jun 15;1(7):e000505. doi: 10.3945/cdn.117.000505. eCollection 2017 Jul.

Reference Type: DERIVED

PMID: 29955710 (View on PubMed)

Other Identifiers

R21AA016110

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R21AA016110

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008P-000164 AAAPILOT

Identifier Type: -

Identifier Source: org_study_id

NCT01377727

Identifier Type: -

Identifier Source: nct_alias