Methyl-Donors and EpiGenetics in The Gambia

Completed

• Conditions: Aberrant DNA Methylation
• Interventions: Other: season, dietary intake

• Registration Number: NCT01811641
• Lead Sponsor: Medical Research Council

Brief Summary

Accumulating evidence suggests that early-life nutrition can affect metabolism and thus increase the risk of disease in adulthood (e.g. type II diabetes and obesity). One possible mechanism to explain these effects is epigenetic variation at critical periods of development. Epigenetic variation describes non-inherited permanent alterations to an individuals DNA.

Recent work in mouse models has demonstrated that maternal nutritional status can affect such epigenetic processes such as DNA methylation and gene expression during embryonic development, with profound effects on outcomes. The investigators aim to study these processes in humans for the first time. The investigators will exploit the "experiment of nature" setting in The Gambia, i.e. fluctuation in diet according to season. During the 'hungry' season diets are known to be depleted in nutrients required for epigenetic gene regulation. Nutritional biomarkers in blood as well as the dietary intake will be measured in pregnant women according to season. A blood sample will also be taken from babies born to these women to determine whether there is a direct effect of diet on mothers' nutritional status and hence variation in DNA methylation patterns in their babies by season.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2012-06
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
maternal methyl-donors, infant epigenetics	season, dietary intake	women of reproductive age in rural Gambia, infants born to these women

Primary Outcome Measures

Name	Time	Method
DNA methylation of infants	infants: at 3-6 months of age	Measurement of DNA methylation of infants recruited into the study, at 3-6 months of age.; Measurement of blood biomarkers monthly after dietary assessment or in early pregnancy

Secondary Outcome Measures

Name	Time	Method
Blood biomarker status of women	monthly for 12 months or in early pregnancy	Measurement of blood biomarkers monthly after dietary assessment or in early pregnancy