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AzTrials

Breast Milk ExpressionNCT03583502

Krill Oil Supplementation: Effects on Breast Milk Composition

A study testing krill oil and fish oil supplement in people with Breast Milk Expression, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Milk Expression
What is being tested?
krill oil and fish oil supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Jun 2016to 31 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ongoing breastfeeding

Who cannot join

  • ongoing LCPUFA supplementation at the time of enrollment

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital

    Bologna, 40138

Other trials in Italy

About this study

Official title: Maternal Supplementation With Krill Oil During Lactation: Effects on Human Milk Long-chain Polyunsaturated Fatty Acids

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.

Read the 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.

Being tested
krill oil and fish oil supplement
Keywords
LCPUFA, DHA, krill oil, supplementation, breast milk
Medical subject headings
Breast Milk Expression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • krill oil and fish oil supplementDietary 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.

Study groups in NCT03583502
Study groupRoleWhat they receive
SupplementedExperimentalkrill oil and fish oil supplement
Receives: Dietary Supplement: krill oil and fish oil supplement
ControlsNo interventionThe control group did not receive any supplementation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast milk excretion of docosahexaenoic acid (DHA)

    Qualitative analysis of DHA concentration in breast milk

    Measured: Baseline (T0)

  2. Breast milk excretion of docosahexaenoic acid (DHA)

    Qualitative analysis of DHA concentration in breast milk

    Measured: After 30 days of supplementation (T1)

Secondary outcomes (4)
  1. Breast milk excretion of eicosapentaenoic acid (EPA)

    Qualitative analysis of EPA concentration in breast milk

    Measured: Baseline (T0)

  2. Breast milk excretion of eicosapentaenoic acid (EPA)

    Qualitative analysis of EPA concentration in breast milk

    Measured: After 30 days of supplementation (T1)

  3. Breast milk excretion of arachidonic acid (AA)

    Qualitative analysis of AA concentration in breast milk

    Measured: Baseline (T0)

  4. Breast milk excretion of arachidonic acid (AA)

    Qualitative analysis of AA concentration in breast milk

    Measured: After 30 days of supplementation (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start1 Jun 2016
  3. Primary completion31 Jul 2017
  4. Study completion31 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03583502
Sponsor's protocol ID
SO-2016-Krilling
Status last verified
Jul 2018
First submitted
27 Jun 2018
Last updated
11 Jul 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cimatti AG, Martini S, Munarini A, Zioutas M, Vitali F, Aceti A, Mantovani V, Faldella G, Corvaglia L. Maternal Supplementation With Krill Oil During Breastfeeding and Long-Chain Polyunsaturated Fatty Acids (LCPUFAs) Composition of Human Milk: A Feasibility Study. Front Pediatr. 2018 Dec 20;6:407. doi: 10.3389/fped.2018.00407. eCollection 2018.

    PubMed 30622936

Questions about this trial

What is this clinical trial studying?

A study testing krill oil and fish oil supplement in people with Breast Milk Expression, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast milk excretion of docosahexaenoic acid (DHA) (time frame: Baseline (T0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03583502, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.

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