Human Milk Lipid Profile Assessment and Influences of Mother's Diet

NCT ID: NCT03808207

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2019-10-30

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.

Conditions

Breastfeeding; Human Milk; Diet Habit; Fatty Acid; Infant Growth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Dietary counseling and DHA dietary increase in breastfeeding mothers

Intervention Type: OTHER

Specific dietary advices in order to increase the daily/weekly intake of docosahexaenoic acid of breastfeeding mothers for the first 3 months after delivery

Control group

No specific dietary advice; Only endorsement and promotion of breastfeeding.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary counseling and DHA dietary increase in breastfeeding mothers

Specific dietary advices in order to increase the daily/weekly intake of docosahexaenoic acid of breastfeeding mothers for the first 3 months after delivery

Intervention Type: OTHER

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Fanaro Silvia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Fanaro, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Science Department, University of Ferrara, Italy

Locations

UO Neonatal Intensive Care Unit and Neonatology

Ferrara, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvia Fanaro, MD

Role: CONTACT

fnrslv@unife.it

+390532236014

Facility Contacts

Silvia Fanaro, MD

Role: primary

Alice Gollini, Student

Role: backup

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HM2018

Identifier Type: -

Identifier Source: org_study_id