Analysis of Lipids in Human Milk at Different Gestational Ages

Breast Milk Collection Clinical Trial

Official title:

Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples at Different Gestational Ages

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989009
• Other study ID #: 1669
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2023
• Source: Ospedale Buon Consiglio Fatebenefratelli
• Contact: Giuseppe De Bernardo, MD
• Phone: 3357441303
• Email: pinodebtin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. The study of lipidomic is of particular interest because the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. The study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk.

Description:

Mother's milk is the best food for the newborn as it is the only one capable of providing species-specific nutrition, guaranteeing everything necessary for the growth and maturation of a child. Mother's milk has the property of satisfying metabolic needs by changes in the composition of nutrients, which are different at each stage of life. Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, such as vitamins, macronutrients, carbohydrates and proteins. The metabolomic study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk. This is particularly important in a Neonatal Intensive Care Unit, where it is essential to ensure timely adequate enteral nutrition. This is possible if a bank of donated human milk is available. The study of lipidomics is of particular interest, as the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. Therefore, the benefit deriving from an adequate dietary intake in a constantly evolving organism such as that of a newborn is extremely important.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Mothers who have given birth in hospital at any gestational age

• Written informed consent

• BMI 18.50-24.99 Kg/m2

• Varied and balanced maternal diet without restrictions

• Weight gain during pregnancy up to 12kg

Exclusion Criteria:

• Food intolerance

• Celiac disease

• Vegan or vegetarian diet

• Diet with the exclusion of milk and derivatives

• Diagnosis of metabolic diseases

• Taking medicines during pregnancy

• Withdrawal of informed consent

Related Conditions & MeSH terms

• Breast Milk Collection

Intervention

Other:
• Breastfeeding
Mothers will breastfeed their newborns

Locations

Country	Name	City	State
Italy	Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital	Napoli
Italy	Department of Pharmacy, University of Salerno	Salerno	Naples

Sponsors (2)

Lead Sponsor	Collaborator
Ospedale Buon Consiglio Fatebenefratelli	University of Salerno

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of a-Linoleic acid (µg/mL) in human milk	7 days after delivery
Primary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk	7 days after delivery
Primary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk	7 days after delivery
Primary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Arachidonic acid (µg/mL) in human milk	7 days after delivery
Primary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Linoleic acid (µg/mL) in human milk	7 days after delivery
Secondary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of a-Linoleic acid (µg/mL) in human milk	1 month after delivery
Secondary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk	1 month after delivery
Secondary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk	1 month after delivery
Secondary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Arachidonic acid (µg/mL) in human milk	1 month after delivery
Secondary	Quantification of essential long-chain polyunsaturated fatty acids in human milk	To assess the concentrations of Linoleic acid (µg/mL) in human milk	1 month after delivery