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Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores

NCT03640104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-28

No results posted yet for this study

Summary

Breast milk is the best food during the first 6mo of life because it offers multiple benefits for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low vitamin A concentration has been observed in northwest Mexico, which can affect the human milk composition and increase the risk of VAD in breastfed babies. An individualized dietary intervention in the lactating woman will reduce body weight and improve vitamin A status. The objective is to assess the effect of an individualized dietary intervention during 3 months postpartum on body composition and vitamin A status of lactating women.

Conditions

  • Overweight and Obesity
  • Vitamin A Deficiency
  • Dietary Modification
  • Breastfeeding

Interventions

BEHAVIORAL

Intervention-Nutrition guidelines

Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.

BEHAVIORAL

Nutrition guidelines

Nutritional recommendations based on international guidelines

Sponsors & Collaborators

  • Centro de Investigación en Alimentación y Desarrollo A.C.

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Universidad de Sonora

    lead OTHER

Principal Investigators

  • Veronica Lopez-Teros, Dr · Universidad de Sonora

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-02-07
Completion
2020-02-07

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640104 on ClinicalTrials.gov