Alcohol Consumption and Circulating Metabolites

Sponsor
International Agency for Research on Cancer (Other)
Overall Status
Completed
CT.gov ID
NCT03402568
Collaborator
Maastricht University (Other), Imperial College London (Other), Danish Cancer Society (Other), University of Aarhus (Other), Centre for Research in Epidemiology and Population Health (CESP) (Other), Gustave Roussy, Cancer Campus, Grand Paris (Other), German Cancer Research Center (Other), German Institute of Human Nutrition (Other), Hellenic Health Foundation (Other), Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other), ISPO Cancer Prevention and Research Institute (Other), Federico II University (Other), HuGeF Foundation (Other), Azienda Sanitaria Provinciale Ragusa (Other), University of Tromso (Other), Catalan Institute of Oncology, Barcelona (Other), Ministry of Health - Government of the Principality of Asturias (Other), Andalusian School of Public Health (Other), Universidad de Murcia (Other), Instituto de Salud Pública Gobierno de Navarra (Other), Subdirección de Salud Pública de Gipuzkoa (Other), Skane University Hospital (Other), Umeå University (Other), MORGEN-EPIC, Bilthoven (Other), Prospect-EPIC, Utrecht (Other), University of Oxford (Other), University of Cambridge (Other)
2,974
48.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2974 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Circulating Metabolites Associated With Alcohol Intake in the European Prospective Investigation Into Cancer and Nutrition Cohort
    Actual Study Start Date :
    Oct 24, 2012
    Actual Primary Completion Date :
    Oct 26, 2016
    Actual Study Completion Date :
    Oct 26, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Circulating metabolite concentrations [Laboratory analyses performed between Oct 2012-Oct 2016]

      Blood concentrations of 123 metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins (BIOCRATES AbsoluteIDQTM p180 kit).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria (for EPIC):
    • 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 (for this study):
    • Individuals without metabolomics data

    • Individuals without data on alcohol consumption at recruitment

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • International Agency for Research on Cancer
    • Maastricht University
    • Imperial College London
    • Danish Cancer Society
    • University of Aarhus
    • Centre for Research in Epidemiology and Population Health (CESP)
    • Gustave Roussy, Cancer Campus, Grand Paris
    • German Cancer Research Center
    • German Institute of Human Nutrition
    • Hellenic Health Foundation
    • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    • ISPO Cancer Prevention and Research Institute
    • Federico II University
    • HuGeF Foundation
    • Azienda Sanitaria Provinciale Ragusa
    • University of Tromso
    • Catalan Institute of Oncology, Barcelona
    • Ministry of Health - Government of the Principality of Asturias
    • Andalusian School of Public Health
    • Universidad de Murcia
    • Instituto de Salud Pública Gobierno de Navarra
    • Subdirección de Salud Pública de Gipuzkoa
    • Skane University Hospital
    • Umeå University
    • MORGEN-EPIC, Bilthoven
    • Prospect-EPIC, Utrecht
    • University of Oxford
    • University of Cambridge

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    International Agency for Research on Cancer
    ClinicalTrials.gov Identifier:
    NCT03402568
    Other Study ID Numbers:
    • PP201712-35
    First Posted:
    Jan 18, 2018
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by International Agency for Research on Cancer
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 23, 2018