BreastfeedingNCT03808207
Human Milk Lipid Profile Assessment and Influences of Mother's Diet
A study testing Dietary counseling and DHA dietary increase in breastfeeding mothers in people with Breastfeeding and Human Milk, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Human Milk, Diet Habit
- What is being tested?
- Dietary counseling and DHA dietary increase in breastfeeding mothers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 6 Aug 2018to 30 Oct 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- women who have delivered at > 33 weeks GA
- ongoing breastfeeding
- consent received
Who cannot join
- contraindications to breastfeeding
- neonatal malformations or genetic anomalies
- language barrier
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UO Neonatal Intensive Care Unit and Neonatology
Ferrara, 44124
Silvia Fanaro, MD
Alice Gollini, Student
About this study
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
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.
Read the detailed description
Breast milk, with its unique and inimitable characteristics, is the ideal feeding for full-term babies. The maternal diet strongly influences the composition of milk, in particular, its lipid proflie, which provides about 50% of the infant's energy needs. In particular, the polyunsaturated fatty acid fraction may varies according ethnic origin and diet habit.
Docosahexaenoic acid or DHA (22: 6 n-3), a long chain fatty acid from the omega 3 series, plays a fundamental role in neurogenesis and neurotransmission as well as in vision, as it is present in both brain, particularly in neural synapses, and in retinal photoreceptors. In particular, the brain grows rapidly from birth to the first year of life, and this growth must be supported by the adequate and balanced intake of all fatty acids; among these we have seen that DHA has a priority role. Observational studies have shown that higher concentrations in breast milk and / or maternal and / or neonatal DHA blood are associated with greater visual acuity, language development, psychomotor development, attention and higher IQ scores in children. The paucity of DHA in the maternal diet of Western countries, and the low conversion rate of α-linolenic acid or ALA (18: 3 n-3) in DHA in humans babies, may result in an insufficient supply for the newborn brain.
Most of the prospective studies carried out in this area have evaluated the effects of maternal supplementation of fish oils, algal oils, chia oil, linseed oil. At present, the positive association between the frequency of fish consumption and DHA levels in breast milk has only been evaluated in retrospective studies.
On these basis, the purpose of this randomized clinical trial is the evaluation of the efficacy of a dietary counseling specifically aimed at increasing the intake of ALA and its long-chain derivatives on the lipid profile of breast milk. Women in the intervention group will be provided an informative scheme on food options with the highest content of the aforementioned polyunsaturated fatty acids. The expected result, at 3 months after delivery, in the intervention group is an increase of DHA in breast milk 80% higher than the value found in the control group (women on a free diet). Dietary habits at enrollment and actual intakes will be recorded for 1 week before the two milk samplings. The research is also aimed at verifying the efficacy of a nutritional educational intervention, without strict preordained schemes, and above all without the aid of dietary supplements.
- Conditions
- Breastfeeding, Human Milk, Diet Habit, Fatty Acid, Infant Growth
- Being tested
- Dietary counseling and DHA dietary increase in breastfeeding mothers
- Keywords
- Docosahexaenoic acid, LcPufas, Diet, Human milk, gas chromatography
- Medical subject headings
- Breast Feeding, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary counseling and DHA dietary increase in breastfeeding mothersOther
Specific dietary advices in order to increase the daily/weekly intake of docosahexaenoic acid of breastfeeding mothers for the first 3 months after delivery
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Increase of the average intake of dietary DHA: dietary advices concerning the concentration of docosahexaenoic acid (DHA) in several foods; the recommended daily or weekly intake of different food options (animal, vegetal) in order to reach the average intake of 300-350 mg DHA/day Receives: Other: Dietary counseling and DHA dietary increase in breastfeeding mothers |
| Control group | No intervention | No specific dietary advice; Only endorsement and promotion of breastfeeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 80 days
Secondary outcomes (1)
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.
Measured: 80 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start6 Aug 2018
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blind randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanaro Silvia, Università degli Studi di Ferrara
- Investigators
- Silvia Fanaro, MD, Principal investigator, Medical Science Department, University of Ferrara, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808207
- Sponsor's protocol ID
- HM2018
- Status last verified
- Jan 2019
- First submitted
- 1 Oct 2018
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03808207
- Acronym / sponsor ID
- HM2018
- Conditions
- Breastfeeding, Human Milk, Diet Habit, Fatty Acid, Infant Growth
- Keywords
- Docosahexaenoic acid, LcPufas, Diet, Human milk, gas chromatography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 17 Jan 2019 (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.
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.
Detailed description
Breast milk, with its unique and inimitable characteristics, is the ideal feeding for full-term babies. The maternal diet strongly influences the composition of milk, in particular, its lipid proflie, which provides about 50% of the infant's energy needs. In particular, the polyunsaturated fatty acid fraction may varies according ethnic origin and diet habit.
Docosahexaenoic acid or DHA (22: 6 n-3), a long chain fatty acid from the omega 3 series, plays a fundamental role in neurogenesis and neurotransmission as well as in vision, as it is present in both brain, particularly in neural synapses, and in retinal photoreceptors. In particular, the brain grows rapidly from birth to the first year of life, and this growth must be supported by the adequate and balanced intake of all fatty acids; among these we have seen that DHA has a priority role. Observational studies have shown that higher concentrations in breast milk and / or maternal and / or neonatal DHA blood are associated with greater visual acuity, language development, psychomotor development, attention and higher IQ scores in children. The paucity of DHA in the maternal diet of Western countries, and the low conversion rate of α-linolenic acid or ALA (18: 3 n-3) in DHA in humans babies, may result in an insufficient supply for the newborn brain.
Most of the prospective studies carried out in this area have evaluated the effects of maternal supplementation of fish oils, algal oils, chia oil, linseed oil. At present, the positive association between the frequency of fish consumption and DHA levels in breast milk has only been evaluated in retrospective studies.
On these basis, the purpose of this randomized clinical trial is the evaluation of the efficacy of a dietary counseling specifically aimed at increasing the intake of ALA and its long-chain derivatives on the lipid profile of breast milk. Women in the intervention group will be provided an informative scheme on food options with the highest content of the aforementioned polyunsaturated fatty acids. The expected result, at 3 months after delivery, in the intervention group is an increase of DHA in breast milk 80% higher than the value found in the control group (women on a free diet). Dietary habits at enrollment and actual intakes will be recorded for 1 week before the two milk samplings. The research is also aimed at verifying the efficacy of a nutritional educational intervention, without strict preordained schemes, and above all without the aid of dietary supplements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Dietary counseling and DHA dietary increase in breastfeeding mothersIncrease of the average intake of dietary DHA: dietary advices concerning the concentration of docosahexaenoic acid (DHA) in several foods; the recommended daily or weekly intake of different food options (animal, vegetal) in order to reach the average intake of 300-350 mg DHA/day |
| Control group | No intervention | –No specific dietary advice; Only endorsement and promotion of breastfeeding. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- women who have delivered at > 33 weeks GA
- ongoing breastfeeding
- consent received
Key exclusion criteria (3 listed)
- contraindications to breastfeeding
- neonatal malformations or genetic anomalies
- language barrier
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 |
|---|---|---|
| Dietary counseling and DHA dietary increase in breastfeeding mothersSpecific dietary advices in order to increase the daily/weekly intake of docosahexaenoic acid of breastfeeding mothers for the first 3 months after delivery | Other | Intervention group |
Primary outcome
Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment
Time frame: 80 days
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.
1 secondary outcome
Lipid profile characteristics in human milk of mothers delivering preterm or term infants
Time frame: 80 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- 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.
Silvia Fanaro, MD principal investigator
Medical Science Department, University of Ferrara, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary counseling and DHA dietary increase in breastfeeding mothers in people with Breastfeeding and Human Milk, run by Università degli Studi di Ferrara 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Fanaro, MD (+390532236014, fnrslv@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment (time frame: 80 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2019.