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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640104
• Other study ID #: VLT-001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: February 7, 2020

Study information

• Verified date: April 2021
• Source: Universidad de Sonora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Nutrition guidelines
Nutritional recommendations based on international guidelines

Locations

Country	Name	City	State
Mexico	Universidad de Sonora	Hermosillo	Sonora

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Sonora	Centro de Investigación en Alimentación y Desarrollo A.C., University of Wisconsin, Madison

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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