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Variations in composition of breast milk between different ethnic groups and the association with maternal nutrition and offspring health

Variations in composition of breast milk between different ethnic groups and the association with maternal nutrition and offspring health - The MELK study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55936
Enrollment
120
Registered
2022-03-17
Start date
2022-07-13
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Breast milk composition

Interventions

None listed

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Aged >18 years •Having a pre-pregnancy BMI between 18.5 and 24.9 kg/m2 •>6 months pregnant at time of enrollment •Able to provide a breast milk sample between the 4th and 8th week postpartum •Planning to exclusively breastfeed until at least 3 months postpartum (this will not include any formula given due to medical reasons within the first week after delivery) •Fulfilling the criteria of belonging to one of the three ethnicities of interest (see 8.1.1) •Written informed consent obtained And her infant was: • Delivered at full term, at 38 (starting at 37+1) -41 weeks • Delivered apparently healthy (no diagnosed (chronic) illness) • Delivered with a birthweight of at least 2,5 kg • Delivered through vaginal delivery • Not receiving antibiotics

Exclusion criteria

Exclusion criteria: Mothers cannot participate if they: • Are expecting twins • Cannot breastfeed their newborn • Are currently deviating from their usual dietary pattern (following a diet aimed to lose weight) •Are experiencing symptoms of (chronic) conditions that might affect nutrient absorption (e.g. Crohn's disease, Irritable Bowel Syndrome) •Are diagnosed with a gastrointestinal disorder • Are unable to read and understand the Dutch or English language

Design outcomes

Primary

MeasureTime frame
- Breast milk composition: analysis of lipids, proteins, enzymes, immuno proteins, hormones, amino-acids and carbohydrates - Maternal diet

Secondary

MeasureTime frame
- Infant gastrointestinal (GI) health - Infant development - Infant gut microbiota composition - Maternal nutritional status

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)