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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03640104
Other study ID # VLT-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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