NCT Number: NCT01811641
Methyl-Donors and EpiGenetics in The Gambia
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
1 day–45 year
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Primary outcomes
-
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
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Medical Research Council
Other Gov
Registry information
Official study title
Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?
Acronym: MDEG
Important dates
- Study start
- 2009
- Primary completion
- 2012
- Study completion
- 2015
- First posted
- Mar 14, 2013
- Registry last updated
- Mar 22, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Aberrant DNA Methylation to Predict Metachronous Gastric Neoplasms
NCT04830618
Aberrant DNA Methylation, Digestive System Diseases
View Trial Details