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Methyl-Donors and EpiGenetics in The Gambia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01811641
Acronym
MDEG
Enrollment
166
Registered
2013-03-14
Start date
2009-01-31
Completion date
2015-12-31
Last updated
2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aberrant DNA Methylation

Keywords

season of conception, maternal nutritional status, infant DNA methylation

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.

Interventions

OTHERseason, dietary intake

Sponsors

Medical Research Council
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 45 Years
Healthy volunteers
Yes

Inclusion criteria

women: \- women aged 18-45 years on 15th March 2009, resident in West Kiang

Exclusion criteria

women: * on contraception * confirmed pregnancy at recruitment * enrolment in any study other than the ENID (Early Nutrition and Immune Development) trial (ISRCTN49285450) * suffering from severe anaemia (haemoglobin \<7 g/dl) or known sickle cell disease Inclusion criteria infants: \- born to the above women

Design outcomes

Primary

MeasureTime frameDescription
DNA methylation of infantsinfants: at 3-6 months of ageMeasurement 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

MeasureTime frameDescription
Blood biomarker status of womenmonthly for 12 months or in early pregnancyMeasurement of blood biomarkers monthly after dietary assessment or in early pregnancy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026