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

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin A Deficiency; Overweight and Obesity; Dietary Modification; Breastfeeding
• Intervention / Treatment: Behavioral: Intervention-Nutrition guidelines; Behavioral: Nutrition guidelines

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Sonora
    • Hermosillo, Sonora, Mexico, 83000
      • Universidad de Sonora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Other: Nutrition Guidelines; Participants will receive general nutritional recommendations according to international standards	Behavioral: Nutrition guidelines; Nutritional recommendations based on international guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Body weight	Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively	Baseline and 3 months after enrollment
Vitamin A liver stores	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	Baseline and 3 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat mass	Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively	Baseline and 3 months after enrollment
Retinol	Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively	Baseline and 3 months after enrollment

Collaborators and Investigators

• Sponsor: Universidad de Sonora
• Collaborators: University of Wisconsin, Madison; Centro de Investigación en Alimentación y Desarrollo A.C.
• Investigators: Principal Investigator: Veronica Lopez-Teros, Dr, Universidad de Sonora

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Food-based intervention; postpartum weight management; hepatic retinol
• Additional Relevant MeSH Terms: Eye Diseases; Nutrition Disorders; Body Weight; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Overweight; Night Blindness; Vitamin A Deficiency
• Other Study ID Numbers: VLT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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