Skip to main content
OpenTrials
Completed

NCT Number: NCT03640104

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight and Obesity Avitaminosis Behavior Body Weight Breast Feeding Breastfeeding Deficiency Diseases Dietary Modification Feeding Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin A Deficiency

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Sonora

Hermosillo, Sonora, 83000, Mexico

About this study

This protocol was approved by the Bioethics Committee of the Department of Medicine and Health Sciences of Universidad de Sonora. A randomized controlled trial will be carried out and participant women will be assigned by simple randomization 1:1 to either the intervention or control group, upon signing an informed consent. At baseline (2wk postpartum), anthropometric (weight, height, mid upper-arm circumference and triceps skinfold thickness) and body composition (DXA) measurements as well as the assessment of vitamin A status (serum and breastmilk retinol and the modified relative dose response) will be performed. The control group will receive only recommendations for a healthy diet in accordance with international standards and will be followed up every month to promote adherence and to assess their nutritional status. On the other hand, the intervention group will receive an individualized macronutrient meal equivalent menu, with nutritional consultations every two weeks. The dietary plan will include 1-1.5 g/kg body weight protein, 30% total fat (preferably mono and polyunsaturated fatty acids), and vitamin A sources (1300 RAE). After 3 months of intervention are completed, baseline measurements will be repeated. Statistical analysis will include descriptive stats and comparisons between groups (t-tests), significance will be defined as P < 0.05.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≥ 25
  • Predominant breastfeeding
  • Signed Informed Consent

Exclusion criteria

  • Multiparity
  • Alcohol, drugs, tobacco intake
  • Use of dietary supplements
  • Active infection (C reactive protein > 6mg/L)
  • External nutritional counseling
  • Pregnancy during the study period
  • Liver disease

Treatment and study plan

Intervention-Nutrition guidelines

Behavioral

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.

Nutrition guidelines

Behavioral

Nutritional recommendations based on international guidelines

Primary outcomes

  1. Total Body weight

    Time frame: Baseline and 3 months after enrollment

    Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively

  2. Vitamin A liver stores

    Time frame: Baseline and 3 months after enrollment

    Stores are calculated as the DR/R ratio. The outcome will be calculated as the difference in change (between baseline and final VA stores within groups) between the intervention and control group, respectively

Secondary outcomes

  1. Body fat mass

    Time frame: Baseline and 3 months after enrollment

    Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively

  2. Retinol

    Time frame: Baseline and 3 months after enrollment

    Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively

Sponsors and collaborators

Lead sponsor

Universidad de Sonora

Other

Collaborators

  • Centro de Investigación en Alimentación y Desarrollo A.C.
  • University of Wisconsin, Madison

Registry information

Official study title

Effect of an Individualized Dietary Intervention on the Body Composition and Vitamin A Status of Breastfeeding Women

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2018
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.