Clinical Trials Directory

Trials / Completed

CompletedNCT01811641

Methyl-Donors and EpiGenetics in The Gambia

Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?

Status
Completed
Phase
Study type
Observational
Enrollment
166 (actual)
Sponsor
Medical Research Council · Other Government
Sex
All
Age
1 Day – 45 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERseason, dietary intake

Timeline

Start date
2009-01-01
Primary completion
2012-06-01
Completion
2015-12-01
First posted
2013-03-14
Last updated
2016-03-22

Source: ClinicalTrials.gov record NCT01811641. Inclusion in this directory is not an endorsement.