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

ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fortified powder milk

    Dietary supplement

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Experimental: Super 1.000 MamáExperimental treatment 1 intervention
Group B: Sham Comparator: No milk consumptionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
Time Frame: breast milk DHA concentration will be assessed at one month postpartum.
2

Mother Zinc concentration

Zinc concentration in mother serum expressed in mg/dl

Time frame
Mother Zinc concentration will be assessed at one month postpartum
3

mother Vit E concentration

α-tocopherol concentration in mother serum expressed in μmol/L

Time frame
Mother's serum α-tocopherol concentration will be assessed at one month postpartum
4

Mother Vit A concentration

Retinol concentration in mother serum expressed in μmol/L

Time frame
Mother's Vit A concentration will be assessed at one month postpartum

Secondary outcomes

Other outcomes

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