Alcohol Consumption and Circulating Metabolites

NCT ID: NCT03402568

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2974 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-24

Study Completion Date

2016-10-26

Brief Summary

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Alcohol consumption is a risk factor for numerous health conditions and an important cause of death. Identifying metabolites associated with alcohol consumption may provide insights into the metabolic pathways through which alcohol may affect human health. The objective of this study is to investigate associations of alcohol consumption with circulating concentrations of 123 metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins. For this purpose, the investigators use data from the European Prospective Investigation into Cancer and Nutrition (EPIC) study and applied a discovery and replication approach.

Detailed Description

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This study used data from 2,974 control participants from four case-control studies on colorectal (n=491), hepatobiliary (n=327), kidney (n=635), and prostate cancer (n=1,521) nested in the EPIC cohort, for which targeted metabolomics data had been acquired. Alcohol consumption at recruitment was self-reported through dietary questionnaires. Metabolite concentrations were measured by tandem mass spectrometry using the BIOCRATES AbsoluteIDQTM p180 kit. Data were randomly divided into discovery (2/3) and replication (1/3) sets. Multivariable linear regression models were used to evaluate confounder-adjusted associations of ln-transformed alcohol consumption with Z-standardized ln-transformed residual metabolite concentrations. Metabolites significantly related to alcohol intake in the discovery set (FDR q-value\<0.05) were further tested in the replication set (Bonferroni-corrected p-value\<0.05). Of the 72 metabolites significantly related to alcohol intake in the discovery set, 34 metabolites were also significant in the replication analysis, including three acylcarnitines, the amino acid citrulline, four lysophosphatidylcholines, 13 diacylphosphatidylcholines, seven acyl-alkylphosphatidylcholines, and six sphingomyelins. Associations with acylcarnitines and phosphatidylcholines were generally positive, while mostly inverse associations were observed with citrulline and sphingomyelins.

This study adds novel knowledge regarding circulating metabolites associated with alcohol consumption, and provides leads for further studies into the underlying biological mechanisms. A better understanding of metabolic pathways affected by alcohol consumption may contribute to the development of mechanism-tailored intervention strategies to prevent and treat alcohol-related conditions. Furthermore, it may help to identify biomarkers of alcohol consumption facilitating early preventive strategies in individuals at-risk for developing alcohol-related morbidities.

Conditions

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No Condition, Focus: Metabolites of Alcohol Consumption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Aged 30-70
* Healthy volunteers residing within defined geographical areas (where study centers are located). Different settings by centre; mostly general population with some exceptions: women of a health insurance company for teachers and school workers (France), women attending breast cancer screening (Utrecht-The Netherlands, and Florence-Italy), mainly blood donors (most centers in Italy and Spain) and a cohort consisting predominantly of vegetarians (the 'health-conscious' group in Oxford, UK).

Exclusion Criteria

* Individuals without metabolomics data
* Individuals without data on alcohol consumption at recruitment
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Centre for Research in Epidemiology and Population Health (CESP)

OTHER

Sponsor Role collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role collaborator

Hellenic Health Foundation

OTHER

Sponsor Role collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role collaborator

ISPO Cancer Prevention and Research Institute

UNKNOWN

Sponsor Role collaborator

Federico II University

OTHER

Sponsor Role collaborator

HuGeF Foundation

UNKNOWN

Sponsor Role collaborator

Azienda Sanitaria Provinciale Ragusa

OTHER

Sponsor Role collaborator

University of Tromso

OTHER

Sponsor Role collaborator

Institut Català d'Oncologia

OTHER

Sponsor Role collaborator

Ministry of Health - Government of the Principality of Asturias

OTHER_GOV

Sponsor Role collaborator

Andalusian School of Public Health

OTHER_GOV

Sponsor Role collaborator

Universidad de Murcia

OTHER

Sponsor Role collaborator

Instituto de Salud Pública Gobierno de Navarra

UNKNOWN

Sponsor Role collaborator

Subdirección de Salud Pública de Gipuzkoa

UNKNOWN

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role collaborator

MORGEN-EPIC, Bilthoven

UNKNOWN

Sponsor Role collaborator

Prospect-EPIC, Utrecht

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PP201712-35

Identifier Type: -

Identifier Source: org_study_id

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