Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition

Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition and Nutritional Status of Iron and DHA in Infant Red Blood Cells.. 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 ) has been designed and developed as part of a key strategy to incorporate in 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 lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.

Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.

To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.

To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.

To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.

To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.

To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Infants; Lactating Mothers
• Intervention / Treatment: Dietary supplement: Fortified powder milk; Other: Powder milk

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Women who attend their child's first check-up within the first month of life, who breastfeed their children, and who consume milk regularly.

Exclusion Criteria:

• Women who have had multiple pregnancies, who receive vitamin or mineral supplements that interfere with the results of the study, and/or women with malabsorption diseases.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Super 1.000 Mamá; Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive a fortified powder milk product formulated and designed specifically for this population.	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.; Other Names: Super 1.000 Mamá
Sham Comparator: Leche comercial; Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk.	Other: Powder milk; Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.; Other Names: Commercial powder milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
breast milk DHA concentration	concentration of DHA in breast milk expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample	breast milk DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth 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 assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Zinc concentration	Zinc concentration in breast milk expressed in mg/dl	breast milk Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Calcium concentration	Calcium concentration in breast milk expressed in mg/dl	breast milk Calcium concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Iron concentration	Calcium concentration in breast milk expressed in mg/dl	breast milk Iron concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
breast milk Iodine concentration	Iodine concentration in breast milk expressed in mg/dl	breast milk Iodine concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mother red blood cell DHA concentration	concentration of DHA in mother red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample	mother serum DHA concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit A concentration	Retinol concentration in mother serum expressed in μmol/L	mother Vit A concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit E concentration	α-tocopherol concentration in mother serum expressed in μmol/L	mother Vit E concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Vit D concentration	25-hidroxi vitamin D concentration in mother serum expressed in ng/ml	mother Vit D concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother Zinc concentration	Zinc concentration in mother serum expressed in mg/dl	mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother hemoglobin concentration	hemoglobin concentration in mother serum expressed in g/dL	mother hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
mother serum ferritin concentration	ferritin concentration in mother serum expressed in ng/ml	mother serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child hemoglobin concentration	hemoglobin concentration in child serum expressed in g/dL	child hemoglobin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child serum ferritin concentration	ferritin concentration in child serum expressed in ng/ml	child serum ferritin concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)
child red blood cell DHA concentration	concentration of DHA in child red blood cell expressed as a percentage of DHA with respect to the total fatty acids contained in the analyzed sample	child red blood cell DHA concentration concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

Collaborators and Investigators

• Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: micronutrients; human milk; vulnerable population; nutritional supplements; esencial fatty acids
• Other Study ID Numbers: UCTH 2024

Drug and device information, study documents

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