DNA MethylationNCT03227003
DNA Methylation and 1-C Metabolism Nutrient Intake
An observational study of DNA Methylation, run by Cancer Council Victoria.
Trial 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… Read more about this study
- Who is it for?
- Ages 27 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Methylation
- How many people
- 5,983 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Missing data in any of the outcome, exposure, or confounders (N=797 excluded)
About this study
Official title: Dietary Intake of One-carbon Metabolism Nutrients and DNA Methylation in Peripheral Blood
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.
- Conditions
- DNA Methylation
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood DNA methylation
Methylation of DNA from peripheral blood, HumanMethylation 450 Beadchip assay
Measured: 2014-2015
Secondary outcomes (1)
Blood DNA methylation
Methylation of DNA from peripheral blood, LINE-1, Alu, Sat2
Measured: 2014-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DNA MethylationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Council Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Milne, Cancer Council Victoria
- Investigators
- Graham G Giles, PhD, Principal investigator, Cancer Council Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227003
- Sponsor's protocol ID
- CEID_methylation_1
- Status last verified
- Jul 2017
- First submitted
- 21 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30101351
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake of One-carbon Metabolism Nutrients and DNA Methylation in Peripheral Blood
- ClinicalTrials.gov ID
- NCT03227003
- Acronym / sponsor ID
- CEID_methylation_1
- Conditions
- DNA Methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,983 participants (actual)
- Lead sponsor
- Cancer Council VictoriaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 27 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Missing data in any of the outcome, exposure, or confounders (N=797 excluded)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood DNA methylation
Time frame: 2014-2015
Methylation of DNA from peripheral blood, HumanMethylation 450 Beadchip assay
1 secondary outcome
Blood DNA methylation
Time frame: 2014-2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Derived from this study: PubMed 30101351Chamberlain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham G Giles, PhD principal investigator
Cancer Council Victoria
Questions about this trial
What is this clinical trial studying?
An observational study of DNA Methylation, run by Cancer Council Victoria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood DNA methylation (time frame: 2014-2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03227003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.