Clinical trial NCT03808207: Human Milk Lipid Profile Assessment and Influences of Mother's Diet
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding
Human Milk
Diet Habit
Fatty Acid
Infant Growth
Keywords: Docosahexaenoic acid
LcPufas
Diet
Human milk
gas chromatography
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 24
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blind randomized clinical trial
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* women who have delivered at \> 33 weeks GA
* ongoing breastfeeding
* consent received

Exclusion Criteria:

* contraindications to breastfeeding
* neonatal malformations or genetic anomalies
* language barrier

Primary outcomes:
measure: Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment
timeFrame: 80 days
Secondary outcomes:
measure: Lipid profile characteristics in human milk of mothers delivering preterm or term infants
timeFrame: 80 days
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: UO Neonatal Intensive Care Unit and Neonatology
Study officials:
affiliation: Medical Science Department, University of Ferrara, Italy
name: Silvia Fanaro, MD
role: PRINCIPAL_INVESTIGATOR
References: