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

NCT03808207 | Unknown

• 1 other identifier: HM2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Docosahexaenoic acid; LcPufas; Diet; Human milk; gas chromatography

Outcome Measures

Primary Outcomes (1)

• 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.

  80 days

Secondary Outcomes (1)

• Lipid profile characteristics in human milk of mothers delivering preterm or term infants

  80 days

Study Arms (2)

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

Other: Dietary counseling and DHA dietary increase in breastfeeding mothers

Control group

NO INTERVENTION

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

Interventions

Dietary counseling and DHA dietary increase in breastfeeding mothers 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

Intervention group

Eligibility Criteria

• Gender Eligibility Details: mother's milk; breastfeeding status
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

UO Neonatal Intensive Care Unit and Neonatology

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Feeding Behavior

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Silvia Fanaro, MD

  Medical Science Department, University of Ferrara, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Fanaro, MD

CONTACT

+390532236014; fnrslv@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The lipid profile will be assessed by an external investigator who is blind for the dietary advices and choices of the single patient. Milk samples are assigned a progressive numerical code.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Blind randomized clinical trial

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: January 17, 2019
• Study Start: August 6, 2018
• Primary Completion: August 30, 2019
• Study Completion: October 30, 2019
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)