NCT03227003

Brief Summary

The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays. The investigators studied the association between nutrients involved in one-carbon metabolism and DNA methylation in peripheral blood.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,983

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 21, 2017

Last Update Submit

July 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood DNA methylation

    Methylation of DNA from peripheral blood, HumanMethylation 450 Beadchip assay

    2014-2015

Secondary Outcomes (1)

  • Blood DNA methylation

    2014-2015

Eligibility Criteria

Age27 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population is a sub-sample of the Melbourne Collaborative Cohort Study (MCCS), with non-random sampling based on selection into of six case-control studies nested within the MCCS. The MCCS is a prospective cohort study of 41,513 people (17,044 men and 24,469 women) recruited between 1990 and 1994. The age range at recruitment was 27-80 (99.3% being aged 40-69). Southern European migrants to Australia were over-sampled to extend the range of exposures, including dietary patterns. Participants in this sub-study had valid dietary intake data and valid measures of DNA methylation.

You may qualify if:

  • Selected into one of six case-control studies nested in the Melbourne Collaborative Cohort Study
  • Completed a 121-item Food Frequency Questionnaire
  • Had a blood DNA sample with a measure of methylation

You may not qualify if:

  • Missing data in any of the outcome, exposure, or confounders (N=797 excluded)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chamberlain JA, Dugue PA, Bassett JK, Hodge AM, Brinkman MT, Joo JE, Jung CH, Makalic E, Schmidt DF, Hopper JL, Buchanan DD, English DR, Southey MC, Giles GG, Milne RL. Dietary intake of one-carbon metabolism nutrients and DNA methylation in peripheral blood. Am J Clin Nutr. 2018 Sep 1;108(3):611-621. doi: 10.1093/ajcn/nqy119.

Study Officials

  • Graham G Giles, PhD

    Cancer Council Victoria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Cancer Epidemiology & Intelligence Division

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 24, 2017

Study Start

January 1, 2014

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

July 24, 2017

Record last verified: 2017-07