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.
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
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.
- Conditions
- Breast Milk Expression
- 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 group | Role | What they receive |
|---|---|---|
| Supplemented | Experimental | krill oil and fish oil supplement Receives: Dietary Supplement: krill oil and fish oil supplement |
| Controls | No intervention | The control group did not receive any supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk excretion of docosahexaenoic acid (DHA)
Qualitative analysis of DHA concentration in breast milk
Measured: Baseline (T0)
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)
Breast milk excretion of eicosapentaenoic acid (EPA)
Qualitative analysis of EPA concentration in breast milk
Measured: Baseline (T0)
Breast milk excretion of eicosapentaenoic acid (EPA)
Qualitative analysis of EPA concentration in breast milk
Measured: After 30 days of supplementation (T1)
Breast milk excretion of arachidonic acid (AA)
Qualitative analysis of AA concentration in breast milk
Measured: Baseline (T0)
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.
- First posted11 Jul 2018
- Study start1 Jun 2016
- Primary completion31 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Milk ExpressionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Corvaglia, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Luigi Corvaglia, Prof, Principal investigator, luigi.corvaglia@unibo.it
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Supplementation With Krill Oil During Lactation: Effects on Human Milk Long-chain Polyunsaturated Fatty Acids
- ClinicalTrials.gov ID
- NCT03583502
- Acronym / sponsor ID
- SO-2016-Krilling
- Conditions
- Breast Milk Expression
- Keywords
- LCPUFA, DHA, krill oil, supplementation, breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemented | Experimental | Dietary Supplement: krill oil and fish oil supplementkrill oil and fish oil supplement |
| Controls | No intervention | –The control group did not receive any supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ongoing breastfeeding
Key exclusion criteria (1 listed)
- ongoing LCPUFA supplementation at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| krill oil and fish oil supplementAdministration 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. | Dietary supplement | Supplemented |
Primary outcome
Breast milk excretion of docosahexaenoic acid (DHA)
Time frame: Baseline (T0)
Qualitative analysis of DHA concentration in breast milk
Breast milk excretion of docosahexaenoic acid (DHA)
Time frame: After 30 days of supplementation (T1)
Qualitative analysis of DHA concentration in breast milk
4 secondary outcomes
Breast milk excretion of eicosapentaenoic acid (EPA)
Time frame: Baseline (T0)
Breast milk excretion of eicosapentaenoic acid (EPA)
Time frame: After 30 days of supplementation (T1)
Breast milk excretion of arachidonic acid (AA)
Time frame: Baseline (T0)
Breast milk excretion of arachidonic acid (AA)
Time frame: After 30 days of supplementation (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Derived from this study: PubMed 30622936Cimatti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Corvaglia, Prof principal investigator
luigi.corvaglia@unibo.it
1 site in 1 country: see every site and its status.
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.