MDEG: Methyl-Donors and EpiGenetics in The Gambia

Sponsor
Medical Research Council (Other)
Overall Status
Completed
CT.gov ID
NCT01811641
Collaborator
(none)
166
83

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: season, dietary intake

Study Design

Study Type:
Observational
Actual Enrollment :
166 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
maternal methyl-donors, infant epigenetics

women of reproductive age in rural Gambia, infants born to these women

Other: season, dietary intake

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 45 Years
Sexes Eligible for Study:
All
Accepts 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
Exclusion criteria infants:
  • those known to be severely malnourished (weight-for-height Z-score < -3)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical Research Council

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matt Silver, MRC Senior Investigator Scientist, Medical Research Council
ClinicalTrials.gov Identifier:
NCT01811641
Other Study ID Numbers:
  • MRC-ING-MDEG
First Posted:
Mar 14, 2013
Last Update Posted:
Mar 22, 2016
Last Verified:
Mar 1, 2016
Keywords provided by Matt Silver, MRC Senior Investigator Scientist, Medical Research Council

Study Results

No Results Posted as of Mar 22, 2016