NCT00786279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

November 5, 2008

Last Update Submit

January 11, 2016

Conditions

Atherosclerosis

Keywords

atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Adherence to alcohol intake and MRI examinations

    6 months

Secondary Outcomes (1)

  • GGT

    Monthly

Study Arms (2)

1

PLACEBO COMPARATOR

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

Other: Ethanol-free beverage

2

EXPERIMENTAL

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

Other: ethanol

Interventions

ethanolOTHER

15 gm ethanol daily for 6 months

2
Ethanol-free beverageOTHER

0 grams ethanol daily for 6 months.

1

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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.

    PMID: 25060690RESULT

  • 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.

    PMID: 29955710DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Kenneth J. Mukamal, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

November 1, 2008

Primary Completion

March 1, 2011

Study Completion

April 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)