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Trial record 60 of 76 for:    Long-chain fatty acids

Krill Oil Supplementation: Effects on Breast Milk Composition

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ClinicalTrials.gov Identifier: NCT03583502
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Milk Expression Dietary Supplement: krill oil and fish oil supplement Not Applicable

Detailed Description:

Long-chain polyunsaturated fatty acids (LCPUFAs), such as docosahexaenoic (DHA, 22:6 n-3) and arachidonic acid (AA, 20:4 n-6), are major building blocks for the lipid bilayer of neuronal and retinal membranes. Brain maturation and visual development start during pregnancy and continue throughout the first year of life; hence, the role of LCPUFAs is greatest during this period.

Like all mammals, humans lack enzymes for the synthesis of n-3 and n-6 precursors of DHA and AA, which are therefore essential fatty acids and need to be provided by dietary sources.

Breast milk (BM) is the first nutritional choice in term and preterm neonates, and is considered an appropriate and natural source of essential fatty acids in this population. Among LCPUFAs, the role of DHA in the early phases of life has gained increased attention over the last 20 years. Several studies have proved the beneficial effects of DHA on visual acuity and learning skills in neonates; some of these trials have also underpinned the importance of dietary DHA sources, showing improved visual acuity in breastfed term neonates or preterm neonates fed LCPUFA-supplemented formula.

The amount of LCPUFAs excreted in BM, however, is significantly influenced by the related maternal dietary intakes, and this is particularly evident for mothers with extremely high fish consumption or on a vegetarian diet.

Sherry et al. have demonstrated that a 6-week supplementation with low or high dose of DHA in lactating women significantly increases DHA concentration in BM and maternal plasma compared with placebo; consistently, breastfed infants of supplemented mothers showed higher plasma DHA levels.

Antarctic krill, a small crustacean belonging to the order Euphausiacea, is by far the most dominant member of the Antarctic zooplankton community, and also represents a rich source of n-3 LCPUFAs, such as DHA and eicosapentaenoic acid (EPA). Compared to fish oil, krill oil has similar DHA contents, but provides higher amounts of EPA. In addition, fish oil fatty acids are mainly stored as triglycerides (TG), whereas in krill oil are predominantly incorporated to phospholipids (PL), with significantly enhanced bioavailability. To date, the effects of maternal supplementation with krill oil during lactation on BM LCPUFAs composition is still an issue for discussion/has not been investigated.

The aim of this pilot study is to evaluate whether oral maternal supplementation with krill oil combined to fish oil in breastfeeding mothers increases BM concentration of DHA.

Breastfeeding mothers of infants admitted to the Neonatal Intensive Care Unit of Sant'Orsola-Malpighi University Hospital, Bologna, Italy, will be consecutively enrolled if a written informed consent to participate in the present study is obtained.

Women enrolled will undergo open randomization to 2 groups. Group 1 will receive 2 gelatin soft capsules per day of a combined krill and fish oil supplement (Krilling D®, Italchimici S.P.A., Milan, Italy), providing 250 mg/day of DHA and 70 mg/day of EPA, for overall 30 days, whereas group 2 will serve as control. Ten ml of fresh mid-BM samples will be collected at baseline (T0) and at day 30 (T1) of supplementation in both groups.

After collection, DHA, AA and EPA contents of BM samples will be analyzed at the laboratory of the Center for Applied Biomedical Research (CRBA) of Sant'Orsola-Malpighi University Hospital, Bologna, Italy, using gas chromatography/mass spectrometry.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Maternal Supplementation With Krill Oil During Lactation: Effects on Human Milk Long-chain Polyunsaturated Fatty Acids
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
Experimental: Supplemented
krill oil and fish oil supplement
Dietary Supplement: krill oil and fish oil supplement
Administration of 2 gelatin soft capsules per day of a combined krill and fish oil supplement, providing 250 mg/day of DHA and 70 mg/day of EPA, for overall 30 days.

No Intervention: Controls
The control group did not receive any supplementation.



Primary Outcome Measures :
  1. Breast milk excretion of docosahexaenoic acid (DHA) [ Time Frame: Baseline (T0) ]
    Qualitative analysis of DHA concentration in breast milk

  2. Breast milk excretion of docosahexaenoic acid (DHA) [ Time Frame: After 30 days of supplementation (T1) ]
    Qualitative analysis of DHA concentration in breast milk


Secondary Outcome Measures :
  1. Breast milk excretion of eicosapentaenoic acid (EPA) [ Time Frame: Baseline (T0) ]
    Qualitative analysis of EPA concentration in breast milk

  2. Breast milk excretion of eicosapentaenoic acid (EPA) [ Time Frame: After 30 days of supplementation (T1) ]
    Qualitative analysis of EPA concentration in breast milk

  3. Breast milk excretion of arachidonic acid (AA) [ Time Frame: Baseline (T0) ]
    Qualitative analysis of AA concentration in breast milk

  4. Breast milk excretion of arachidonic acid (AA) [ Time Frame: After 30 days of supplementation (T1) ]
    Qualitative analysis of AA concentration in breast milk



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- ongoing breastfeeding

Exclusion Criteria:

- ongoing LCPUFA supplementation at the time of enrollment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583502


Locations
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Italy
Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: Luigi Corvaglia, Prof luigi.corvaglia@unibo.it

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luigi Corvaglia, Associate Professor, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03583502     History of Changes
Other Study ID Numbers: SO-2016-Krilling
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
LCPUFA
DHA
krill oil
supplementation
breast milk