nderstanding the impact of maternal diet and ethnicity on the composition of breast milk
- Conditions
- Breast milk composition and infant GI healthDigestive System
- Registration Number
- ISRCTN35735283
- Lead Sponsor
- Wageningen University & Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 120
Current inclusion criteria as of 21/12/2023:
Mothers:
1. Aged >18 years
2. Having a pre-pregnancy BMI between 18.5 and 24.9 kg/m²
3. >6 months pregnant at time of enrollment
4. Able to provide a breast milk sample between the 4th and 8th week postpartum
5. 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)
6. Fulfilling the criteria of belonging to one of the three ethnicities of interest (see Snijder, M.B., et al., Cohort profile: the Healthy Life in an Urban Setting (HELIUS) study in Amsterdam, The Netherlands. BMJ Open, 2017. 7(12): p. e017873.)
7. Written informed consent obtained
Infants:
8. Delivered at full term (at 38-41 weeks)
9. Delivered apparently healthy (no diagnosed (chronic) illness)
10. Delivered with a birthweight of at least 2.5 kg
11. Delivered through vaginal delivery
12. Not receiving antibiotics
_____
Previous inclusion criteria:
1. Aged >18 years
2. Having a pre-pregnancy BMI between 18.5 and 24.9 kg/m²
3. >6 months pregnant at time of enrollment
4. Able to provide a breast milk sample between the 4th and 8th week postpartum
5. 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)
6. Fulfilling the criteria of belonging to one of the three ethnicities of interest (see Snijder, M.B., et al., Cohort profile: the Healthy Life in an Urban Setting (HELIUS) study in Amsterdam, The Netherlands. BMJ Open, 2017. 7(12): p. e017873.)
7. Written informed consent obtained
And her infant was:
8. Delivered at full term (at 39-41 weeks)
9. Delivered apparently healthy (no diagnosed (chronic) illness)
10. Delivered with a birthweight of at least 2.5 kg
11.Delivered through vaginal delivery
12. Not receiving antibiotics
Current exclusion criteria as of 21/12/2023:
Mothers will be excluded from participation if they:
1. Are expecting/gave birth to twins
2. Cannot breastfeed their newborn
3. Are already breastfeeding another infant
4. Are currently deviating from their usual dietary pattern (following a diet aimed to lose weight)
5. Are diagnosed with a gastrointestinal disorder
6. Are unable to read and understand the Dutch or English language
_____
Previous exclusion criteria:
1. Expecting/gave birth to twins
2. Cannot breastfeed their newborn
3. Currently deviating from their usual dietary pattern (following a diet aimed to lose weight)
4. Are unable to read and understand the Dutch language
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Breast milk is collected in the morning of study days 2 and 3, by means of a manual pump. Breast milk composition will be analyzed by Gas chromatography, DUMAS and High-performance liquid chromatography.
- Secondary Outcome Measures
Name Time Method 1. Infant GI health, assessed by modified version of the IGSQ questionnaire on study day 4<br>2. Infant gut microbiota, measured by 16S rRNA gene amplicon sequencing of infant stool sample, taken on study day 2<br>3. Infant development, measured by Ages and Stages Questionnaire (ASQ) on study day 5