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van CCT (UK)

van CCT (UK)

Effect of maternal diet on breast milk composition

- candidate number15937
- NTR NumberNTR4335
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-dec-2013
- Secondary IDsAnne Schaafsma FrieslandCampina
- Public TitleEffect of maternal diet on breast milk composition
- Scientific TitleRelationship between Vietnamese breast milk composition, maternal diet and maternal and offspring microbiome
- hypothesisThe maternal diet is highly responsible for the composition of breast milk which will result in at least differences between cultures and geographical separated populations. The maternal diet and breastmilk composition will show off in the composition of of the infant's gastrointestinal microbiome, tracking into childhood
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria• Apparently healthy, well-nourished Vietnamese lactating women, who gave normal vaginal birth to an apparently healthy term infant (± 4 weeks old).
• No pregnancy complications
• This new-born, with normal birth proportion according to the region, is at least their second child and the new born is breastfed (at least 75% of total diary milk intake)
• Apparently healthy brother or sister in the age of 1-4 years, with no signs of diarrhea and who were breastfed during the first months of infancy
- Exclusion criteria• Medication that may influence the breast milk composition (medicines that require a special diet, or disturb appetite, or are known to affect the intestinal bacteria)
• Maternal BMI before pregnancy was not in the normal range (<23).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 25-nov-2013
- planned closingdate28-feb-2014
- Target number of participants100
- InterventionsNo intervention. . This study will investigate possible differences in breast milk composition from Vietnamese women living in urban (Hanoi and HCMC) and rural (Ha Long Bay [fish-eating], Phu Tho and Tien Giang [rice-fish-eating]) regions.
- Primary outcomeComposition of breast milk and its relationship with the maternal diet, Microbiome of the breastfed infant
- Secondary outcomeRelationship between the microbiome of the breastfed infant and the microbiome of an older brother or sister
- TimepointsBreast milk and fecal samples are taken around the 4th week of lactation.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Groningen (UMCG), National Institute for Food Control
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryIt is well known that breast milk composition differs from mother to mother. There is compiling evidence that the maternal diet (life long and short term) has an enormous effect on breast milk composition. This study will investigate possible differences in breast milk composition from Vietnamese women living in urban (Hanoi and HCMC) and rural (Ha Long Bay [fish-eating], Phu Tho and Tien Giang [rice-fish-eating]) regions. It is expected that within Vietnam relatively big differences will exist between breast milk compositions from mothers from the here fore mentioned regions. Since breast milk is a strong determinant for the type of intestinal microbiome to develop in the infant during the breastfeeding period, and this developed microbiome is considered to have a relevant impact on the microbiome at older age, faeces will be collected from the breast fed infants, as well as from brothers or sisters (1-4 years of age) that have been breastfed before. Furthermore, the maternal intestinal microbiome is considered to be of importance (as aninoculant) for infant’s intestinal microbiome.
- Main changes (audit trail)
- RECORD24-dec-2013 - 10-jan-2014

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