DNA Methylation and 1-C Metabolism Nutrient Intake | NCT03227003

Studies
DNA Methylation and 1-C Metabolism Nutrient Intake

NCT03227003

Sponsor

Cancer Council Victoria

Status

Completed

Last Update Posted

Jul 24, 2017Actual

Enrollment

5,983Actual

Phase

Not provided

Conditions

DNA Methylation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Jul 21, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2017

Last Update Posted Date

Jul 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,983Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood DNA methylation	Methylation of DNA from peripheral blood, HumanMethylation 450 Beadchip assay	2014-2015

Secondary Outcomes

Measure	Description	Time Frame
Blood DNA methylation	Methylation of DNA from peripheral blood, LINE-1, Alu, Sat2	2014-2015

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

27 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Graham G Giles, PhD	Cancer Council Victoria	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30101351	Derived	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.