CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Experimental intervention group with enriched cookiesdietary
Likely dose
Not stated in record
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Search/NCT04915638
NCT04915638N/ACompleted

Evaluation of Nutritional Status in Chimalhuacán Children: Anthropometric, Biochemical, and Molecular Approaches

Marta Alicia Menjivar Iraheta·interventional·Posted Jun 7, 2021·Updated Jun 7, 2021

In Brief

A clinical study evaluating Experimental intervention group with enriched cookies for Overweight and Obesity and 3 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed Summary

Malnutrition is an epidemiologic problem with high prevalence in Mexico. Mexican children present a double burden of malnutrition characterized by the coexistence of undernutrition and micronutrient deficiency alongside excess body weight. Malnutrition is caused by inadequate nutrition, including micronutrients deficiencies, in which children living in rural areas and indigenous populations are disproportionately affected. Malnutrition has been associated with an increased risk of metabolic abnormalities like metabolic syndrome (MS), diabetes, and cardiovascular disease in adulthood. Nutrition-specific interventions are strategies that may reduce or avert malnutrition in children. However, limited intervention studies have been implemented in low-income populations, particularly in rural areas. Therefore, studies that include nutrition-specific intervention with enriched foods aimed at reducing micronutrients deficiencies and that can help in prevention or treatment of metabolic conditions in these populations are still needed. Based on the nutritional characterization carried out in school children in Chimalhuacán, Mexico State, a formula in a powder form was designed for children containing vitamins, minerals, antioxidants, and omega-3 fatty acids that can be used to enrich foods. The present study aimed to evaluate the effect of a 4-week intervention with cookies enriched with a micronutrient formula on the nutritional status in Maya schoolchildren aged 8-10 years. Participants (n=84) were their own control, and the investigators measured, at pre- and post-intervention, anthropometric, clinical, biochemical, and cognitive parameters; diet and molecular parameters were assessed only at pre-intervention. Chi-square test, t-Student paired or Wilcoxon, ANCOVA, and logistic regression were performed to analyze the data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 7, 2021
Enrollment StartFeb 15, 2018
Primary CompletionApr 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.1 years ago

Interventions

Experimental intervention group with enriched cookiesdietary

Enriched cookies containing a micronutrients formula (vitamins, minerals, antioxidants, and omega-3 fatty acids) each day (Monday to Friday).