Breastfeeding Clinical Trial
Official title:
Human Milk Lipid Profile Assessment and Influences of Mother's Diet Valutazione Del Profilo Lipidico Del Latte Materno e Della Sua Variazione in Relazione Alla Dieta Materna
NCT number | NCT03808207 |
Other study ID # | HM2018 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 6, 2018 |
Est. completion date | October 30, 2019 |
Human milk profile is unique and diet exerts a pivot role in determing its composition.
As a rule, nursing mothers do not receive specific nutritional indications aimed at improving
the lipid profile of milk, despite the scientific evidence in favor of the importance of DHA
in the infant's diet.
The research aims to determine the effect of a dietary counseling specifically targeted at
increasing the intake of fatty acids ω3 (DHA, EPA and ALA) on the lipid profile of breast
milk, in order to identify effective and viable nutrition claims for breastfeeding women.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | October 30, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - women who have delivered at > 33 weeks GA - ongoing breastfeeding - consent received Exclusion Criteria: - contraindications to breastfeeding - neonatal malformations or genetic anomalies - language barrier |
Country | Name | City | State |
---|---|---|---|
Italy | UO Neonatal Intensive Care Unit and Neonatology | Ferrara |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Ferrara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment | Lipid profile assesment of human milk at 10 days and 3 months after delivery. Evaluation of the effect of DHA/ALA diet enrichment during the study period. Measurement of total fat (g/100 ml), saturated fatty acids, monounsaturated fatty and polyunsaturated fatty acids concentration (mg/100 ml), and specifically LA, ALA, ARA, DHA and EPA concentration (mg/100 ml) will be performed with gas chromatograph coupled to a MS / MS mass spectrometer. | 80 days | |
Secondary | Lipid profile characteristics in human milk of mothers delivering preterm or term infants | Lipid profile characteristics in human milk of mothers who delivered 34-36 weeks and 6 days or >37 weeks gestational age infants. Measurement of total fat (g/100 ml), saturated fatty acids, monounsaturated fatty and polyunsaturated fatty acids concentration (mg/100 ml), and specifically LA, ALA, ARA, DHA and EPA concentration (mg/100 ml) will be performed with gas chromatograph coupled to a MS / MS mass spectrometer. |
80 days |
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