DNA methylation, growth, body composition, neuro-development, cardio-metabolic risk, bone health Nutritional, Metabolic, Endocrine
Conditions
Interventions
The EMPHASIS study is an observational study of DNA methylation in two cohorts of children who were born to mothers who took part in two separate completed randomised trials of nutritional interventio
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Age
5 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. Healthy children aged five to seven years participating in the SARAS KIDS study (2013-2018) who were born as singleton live births to mothers who took part before and during pregnancy in the Mumbai Maternal Nutrition Project in India (http://www.isrctn.com/ISRCTN62811278) and who started supplementation at least 3 months prior to conception 2. Healthy children aged five to seven years in the Gambia who were born as singleton live births to mothers who took part in the Peri-conceptional Multiple Micronutrient Supplementation Trial (http://www.isrctn.com/ISRCTN13687662) in the Gambia 3. Parents consented to their participation in follow-up studies in which size, body composition, cardio-metabolic risk markers, cognitive function, and bone health were measured 4. Consented to the use of their DNA samples for this research 5. Samples contained sufficient DNA
Exclusion criteria
Exclusion criteria: Children whose mothers took part in the Mumbai trial but who did not start supplementation at least 3 months before conception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effects of maternal supplementation on the children's DNA methylation: 1. Epigenome wide DNA methylation is measured in the children’s blood DNA samples using Illumina Infinium Methylation EPIC arrays at age 5-7 y (India) and 7-9 y (The Gambia) 2. Locus-specific DNA methylation is measured in blood and buccal DNA samples using pyrosequencing on Pyromark 96 at age 5-7 y (India) and 7-9 y (The Gambia) The associations of DNA methylation with phenotype in the children: 1. Birth weight and length are measured using digital weighing scales and a neonatal stadiometer respectively, within 10 days (India) or 72 hours (The Gambia) of birth. Smallness for gestational age (SGA) is calculated from measured birth weight using the INTERGROWTH reference. 2. Children’s weight and height are measured using standardised anthropometric methods (body mass index is calculated from these measures) at age 5-7 y (India) and 7-9 y (The Gambia) 3. Children’s total and regional lean mass, fat mass and body fat percent are measured using dual-energy X-ray absorptiometry (DXA, Lunar Prodigy in India, Lunar iDXA in The Gambia) (lean mass index and fat mass index are calculated from these measures) at age 5-7 y (India) and 7-9 y (The Gambia) 4. Children’s fasting plasma glucose concentration, and 30-and 120-minute plasma glucose concentrations after an oral glucose load, are measured using standard enzymic assays by autoanalyser at age 5-7 y (India) and 7-9 y (The Gambia) 5. Children’s fasting and 30-minute plasma insulin concentrations are measured using Mercodia ELISA on a Victor 2 analyser (India) and an SM-chemiluminescence method (The Gambia) at age 5-7 y (India) and 7-9 y (The Gambia). Insulin resistance is calculated from fasting glucose and insulin values using the HOMA-IR Oxford online calculator. Disposition index is calculated from fasting and 30-minute plasma glucose and insulin values using standard formulae. 6. Children’s resting systolic blood pressures is measured using an OM | — |
Secondary
| Measure | Time frame |
|---|---|
| The associations of DNA methylation with phenotype in the children: 1. Newborn head, chest, abdominal and mid-upper-arm circumferences are measured using anthropometric tape within 10 days (India) or 72 hours (The Gambia) of birth 2. Newborn triceps and subscapular skinfolds are measured using Holtain skinfold calipers within 10 days (India) or 72 hours (The Gambia) of birth 3. Newborn gestational age at birth was derived from the mother’s last menstrual period (LMP) date and early pregnancy fetal ultrasound measurements, both recorded prospectively by the research team. The number and percentage of pre-term newborns (<37 weeks completed gestation) are derived using gestational age. 4. Newborn low birth weight (<2500g) is derived from measured birth weight 5. Children’s sitting height, leg length, head circumference, mid-upper arm circumference, chest circumference, waist circumference, hip circumference, and skinfolds are measured using standardised anthropometric methods at age 5-7 y (India) and 7-9 y (The Gambia). Sitting height/leg length ratio, sum of skinfolds and waist/hip ratio are calculated from these measures. Longitudinal indices of growth are derived from these measurements and weight, height and body mass index, using conditional and other modelling techniques. 6. The number and percentage of children stunted, wasted, and underweight are derived from measured weight and height at age 5-7 y (India) and 7-9 y (The Gambia) using the World Health Organization/ Centers for Disease Control child growth reference (www.who.int/childgrowth/en/) 7. Children’s android and gynoid fat mass are measured using DXA at age 5-7 y (India) and 7-9 y (The Gambia) 8. Children’s resting diastolic blood pressures is measured using an OMRON automated blood pressure device, after at least 5 minutes seated at rest at age 5-7 y (India) and 7-9 y (The Gambia) 9. Children’s plasma insulin concentration 30-minutes after an oral glucose load is measured using Mercodia ELISA on a Vic | — |
Countries
England, Gambia, India, United Kingdom
Contacts
Public ContactCaroline Fall
Outcome results
None listed