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

NCT06319079 | Recruiting

• 1 other identifier: UCTH 2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lactating Mothers; Infants

Keywords

human milk; vulnerable population; micronutrients; esencial fatty acids; nutritional supplements

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (10)

• mother red blood cell DHA concentration

  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

  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

  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

  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

  mother Zinc concentration will assessed before starting the intervention (one month postpartum) and at the end of it (fourth month postpartum)

Study Arms (2)

Super 1.000 Mamá

EXPERIMENTAL

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

Leche comercial

SHAM COMPARATOR

Breastfeeding mothers who breastfeed their children during the first four months postpartum will receive commercial powder milk.

Other: Powder milk

Interventions

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.

Also known as: Super 1.000 Mamá

Super 1.000 Mamá

Powder milk OTHER

Commercial powder milk constitutes dehydrated commercially available cow's milk, which is fortified with Vitamins A and D by law.

Also known as: Commercial powder milk

Leche comercial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Instituto de Desarrollo e Investigaciones Pediátricas (IDIP) - HIAEP Sor María Ludovica

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

MeSH Terms

Interventions

Refit milk powder

Central Study Contacts

Maria Florencia Andreoli, PhD

CONTACT

542214177324; mfandreoli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The powder milk containers (both SMM and commercial milk) will be packaged by Addvance SA (in the Province of Santa Fe), each of the products will have a label that differentiates them but only the company Addvance SA will know that information. In this project, neither the participating mothers, researchers, and technical staff assigned to the project nor the professional who performs the data analysis knows what product each participant will receive.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

AR (1)