Methyl-Donors and EpiGenetics in The Gambia (MDEG)
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|ClinicalTrials.gov Identifier: NCT01811641|
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 22, 2016
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.
|Condition or disease||Intervention/treatment|
|Aberrant DNA Methylation||Other: season, dietary intake|
|Study Type :||Observational|
|Actual Enrollment :||166 participants|
|Official Title:||Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||December 2015|
maternal methyl-donors, infant epigenetics
women of reproductive age in rural Gambia, infants born to these women
|Other: season, dietary intake|
- DNA methylation of infants [ Time Frame: 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
- Blood biomarker status of women [ Time Frame: monthly for 12 months or in early pregnancy ]Measurement of blood biomarkers monthly after dietary assessment or in early pregnancy
Biospecimen Retention: Samples With DNA