Lessons and Challenges from a 6-Month Randomized Pilot Study of Daily Ethanol Consumption: Research Methodology and Study Design.

ABSTRACT: Background: Observational studies and crossover feeding studies suggest that moderate alcohol use may benefit cardiovascular risk, but we know of no long-term randomized trials that have tested this hypothesis. Objective: We evaluated the feasibility of an efficacy study of daily ethanol use in a 6-mo randomized pilot study in adults at higher cardiovascular risk. Methods: In a double-blind, randomized, controlled parallel-design trial, we screened 67 adults aged ≥55 y and randomly assigned 45 participants to consume 150 mL of an artificially sweetened beverage with or without 10% grain alcohol daily for 6 mo. Participants were asked to consume no other alcohol and returned monthly to receive the beverage and undergo measurement of HDL cholesterol, liver function tests

SUBMITTER: Mukamal KJ 

PROVIDER: S-EPMC5998356 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature