Alcohol Consumption and Circulating Metabolites

No Condition, Focus: Metabolites of Alcohol Consumption Clinical Trial

Official title:

Circulating Metabolites Associated With Alcohol Intake in the European Prospective Investigation Into Cancer and Nutrition Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402568
• Other study ID #: PP201712-35
• Status: Completed
• Phase: N/A
• First received: January 10, 2018
• Last updated: January 19, 2018
• Start date: October 24, 2012
• Est. completion date: October 26, 2016

Study information

• Verified date: January 2018
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2974
• Est. completion date: October 26, 2016
• Est. primary completion date: October 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• No Condition, Focus: Metabolites of Alcohol Consumption

Locations

Country	Name	City	State
n/a

Sponsors (28)

Lead Sponsor

Collaborator

International Agency for Research on Cancer

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating metabolite concentrations	Blood concentrations of 123 metabolites including amino acids, acylcarnitines, hexoses, biogenic amines, phosphatidylcholines, and sphingomyelins (BIOCRATES AbsoluteIDQTM p180 kit).	Laboratory analyses performed between Oct 2012-Oct 2016