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Clinical Trial Summary

The objective of the proposed study is to enroll women with obesity that will undergo a controlled, energy restricted feeding intervention to test the effects of chronic ethanol consumption on adipose distribution and circulating testosterone during weight loss.


Clinical Trial Description

Alcohol (i.e. ethanol) is one of the most widely used recreational substances by humans and is consumed regularly by much of the U.S. population. Despite the high prevalence of alcohol intake, the metabolic health effects associated with use have not been firmly established. There is a paucity of data from longitudinal studies in humans that examine the metabolic response to routine alcohol consumption in a randomized controlled trial (RCT).

This is a novel pilot study to examine, for the first time, the effects of ethanol consumption on fat distribution and testosterone during weight loss in a RCT. Findings from this study would provide insight into an interesting and unanswered question -- does routine alcohol intake exert unfavorable health effects despite the expected beneficial outcomes of caloric restriction and weight loss? This research may provide new knowledge of the metabolic outcomes resulting from alcohol intake and pathways that may be involved leading to potential new therapeutic targets of treatment.

The objective of the proposed study is to enroll women with obesity that will undergo a controlled, energy restricted feeding intervention to test the effects of chronic ethanol consumption on adipose distribution and circulating testosterone during weight loss. Women will be randomized to an ethanol-free control group or an ethanol-consuming group, and all will consume 30% energy-restricted diets. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03521817
Study type Interventional
Source Pennington Biomedical Research Center
Contact John W Apolzan, PhD
Phone 2257632827
Email john.apolzan@pbrc.edu
Status Recruiting
Phase N/A
Start date May 18, 2018
Completion date April 30, 2019

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