Breast Milk Expression Clinical Trial
Official title:
Maternal Supplementation With Krill Oil During Lactation: Effects on Human Milk Long-chain Polyunsaturated Fatty Acids
Verified date | July 2018 |
Source | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Docosahexaenoic acid (DHA) belongs to long-chain polyunsaturated fatty acids (LCPUFAs)
category and is a major building block for neuronal and retinal membranes, playing a crucial
role in brain and visual development within the first months of life. Due to the lack of
enzymes for the synthesis of its precursors, neonates strictly rely on dietary intakes of
DHA. Antarctic krill (Euphausia superba) is a small crustacean rich in phospholipid-bound
DHA, which is highly bioavailable, but whether it is effective in increasing DHA excretion in
breast milk (BM) has not been investigated yet.
This study aims to evaluate whether maternal supplementation with krill oil during
breastfeeding increases DHA contents in breast milk BM.
Mothers of infants admitted to the Neonatal Intensive Care Unit will be enrolled in this
open, randomized, controlled study and randomly allocated in 2 groups. Group 1 will receive
an oral krill oil-based supplement providing 250 mg/day of DHA and 70 mg/day of EPA for 30
days, whereas group 2 serves as control. BM samples from both groups will be collected at
baseline (T0) and day 30 (T1) and will undergo a qualitative analysis of LCPUFAs composition
by gas chromatography/mass spectrometry.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 31, 2017 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - ongoing breastfeeding Exclusion Criteria: - ongoing LCPUFA supplementation at the time of enrollment |
Country | Name | City | State |
---|---|---|---|
Italy | Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital | Bologna |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast milk excretion of docosahexaenoic acid (DHA) | Qualitative analysis of DHA concentration in breast milk | Baseline (T0) | |
Primary | Breast milk excretion of docosahexaenoic acid (DHA) | Qualitative analysis of DHA concentration in breast milk | After 30 days of supplementation (T1) | |
Secondary | Breast milk excretion of eicosapentaenoic acid (EPA) | Qualitative analysis of EPA concentration in breast milk | Baseline (T0) | |
Secondary | Breast milk excretion of eicosapentaenoic acid (EPA) | Qualitative analysis of EPA concentration in breast milk | After 30 days of supplementation (T1) | |
Secondary | Breast milk excretion of arachidonic acid (AA) | Qualitative analysis of AA concentration in breast milk | Baseline (T0) | |
Secondary | Breast milk excretion of arachidonic acid (AA) | Qualitative analysis of AA concentration in breast milk | After 30 days of supplementation (T1) |
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