Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk

Effect of Consumption of a Dairy Product Designed for Pregnant and Lactating Women on the Composition of Human Milk. A Quasi-experimental Study in a Vulnerable Population

Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients, and this will have consequences on the growth and development of the child. In 2021, at IDIP, a specific milk product for pregnant and lactating women, Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals, and DHA ) was designed and developed as part of a key strategy to incorporate into public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level. The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for pregnant women on maternal nutritional status and the composition of human milk at one month postpartum.

Specific objectives include:

To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc, and Calcium in human milk at one month postpartum of mothers who consumed SSM or not.

To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron between mothers who consumed SSM and those who did not.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Dietary supplement: Fortified powder milk

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria F Andreoli, PhD; Phone Number: 542214177324; Email: mfandreoli@gmail.com

Study Locations

• Argentina
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1900
      • Recruiting
      • Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica
      • Contact: Ignacio A Mendez, MS Nutrition; Phone Number: 01158671615; Email: ignacioagustinmg@gmail.com
    • La Plata, Buenos Aires, Argentina, 1900
      • Recruiting
      • Hospital Interzonal de Agudos General San Martín
      • Contact: Sofia A Rui, Bachelor degree nutrition; Phone Number: 5492281566075; Email: sofiaarui@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Intervention group: Pregnant women over 18 years of age who undergo prenatal care during gestational weeks (GW) 28 ± 1 at the Maternal Nutrition Clinic of the H.I.G.A. "San Martín" in La Plata, and who regularly consume milk, will be included.
• Control group: Women over 18 years of age who attend their child's first checkup before the first month of life at the Maternal Clinic of the IDIP Health Observatory, and who exclusively breastfeed their children, will be included.

Exclusion Criteria:

• Women who have had multiple pregnancies and/or women with malabsorption diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Super 1.000 Mamá; Pregnant women who will consume a fortified powdered dairy product formulated and designed specifically for this population during pregnancy and the first month postpartum.	Dietary supplement: Fortified powder milk; Super 1.000 Mamá It's made up of milk with added vegetable oils, fish oil, carbohydrates from corn, prebiotic fiber (inulin), vitamins, and minerals, with specifically defined proportions. It has medium energy content, is balanced in protein, fats, and carbohydrates, and provides a significant content of both polyunsaturated fatty acids, such as omega-6, and omega-3, and the added docosahexaenoic acid, as recommended by international organizations. The reconstituted 200 ml serving delivers between 20 and 40% of the Daily Reference Intake in critical nutrients for this particular group of people, which include minerals such as calcium, iron, zinc, iodine, and vitamins such as A, D, C, B12 and folic acid. The rest of the vitamins, and minerals are also at the same level, allowing those who consume it to incorporate a large amount of nutrients regularly. Addvance SA, an SME dairy company from the Province of Santa Fe, will carry out the production of this milk.
No Intervention: Sham Comparator: No milk consumption; Breastfeeding women who have not consumed SMM until the first month postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast milk DHA concentration	Description: concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample	Time Frame: breast milk DHA concentration will be assessed at one month postpartum.
Mother Zinc concentration	Zinc concentration in mother serum expressed in mg/dl	Mother Zinc concentration will be assessed at one month postpartum
mother Vit E concentration	α-tocopherol concentration in mother serum expressed in μmol/L	Mother's serum α-tocopherol concentration will be assessed at one month postpartum
Mother Vit A concentration	Retinol concentration in mother serum expressed in μmol/L	Mother's Vit A concentration will be assessed at one month postpartum
Mother red blood cell DHA concentration	Concentration of DHA in mother's red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample	Mother's serum DHA concentration will be assessed at one month postpartum
Mother hemoglobin concentration	hemoglobin concentration in mother serum expressed in g/dL	Mother's hemoglobin concentration will be assessed one month postpartum
Breast milk Vitamin A concentration	Retinol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample	Breast milk Vitamin A concentration will be assessed at one month postpartum
Breast milk Vitamin E concentration	α-tocopherol concentration in breast milk expressed in μmol/L and μg/g fat contained in the analyzed sample	Breast milk Vitamin E concentration will be assessed at one month postpartum
Breast milk Vitamin D concentration	25-hidroxi vitamin D concentration in breast milk expressed in ng/ml	Breast milk Vitamin D concentration will be assessed at one month postpartum
Breast milk Zinc concentration	Zinc concentration in breast milk expressed in mg/dl	Breast milk Zinc concentration will be assessed at one month postpartum
Breast milk Calcium concentration	Calcium concentration in breast milk expressed in mg/dl	Breast milk Calcium concentration will be assessed at one month postpartum
Breast milk Iron concentration	Iron concentration in breast milk expressed in mg/dl	Breast milk Iron concentration will be assessed at one month postpartum
Breast milk Iodine concentration	Iodine concentration in breast milk expressed in mg/dl	Breast milk Iodine concentration will be assessed at one month postpartum
Mother serum ferritin concentration	ferritin concentration in mother serum expressed in ng/ml	Mother's serum ferritin concentration will be assessed at one month postpartum
mother Vit D concentration	25-hidroxi vitamin D concentration in mother serum expressed in ng/ml	mother Vit D concentration will be assessed at one month postpartum

Collaborators and Investigators

• Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
• Collaborators: Hospital Interzonal de Agudos General San Martín

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 12, 2025
• First Posted (Estimated): September 15, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: micronutrients; pregnancy; human milk; vulnerable population; nutritional supplements; esencial fatty acids
• Other Study ID Numbers: UCTH 2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No