Status
Conditions
Treatments
About
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.
Full description
Mexican children face both forms of malnutrition: under- and overnutrition. Malnutrition is common among children living in rural areas and indigenous populations, where children suffer from food insecurity and cannot access quality nutrition with adequate micronutrients levels. Studies with vulnerable population groups, such as children, in Mexico have shown that micronutrient deficiencies of vitamins A, E, D, C, and minerals like iron, zinc, calcium, and selenium exist. Micronutrient deficiencies can affect physiology functions, growth of children, cognitive function, and impair metabolic processes at biochemical and cellular level. Furthermore, the early exposure of children to malnutrition, in conjunction with the existence of genetic susceptibility, may predispose children to develop metabolic abnormalities like metabolic syndrome (MetS). Thus, increasing the risk of children developing diabetes and cardiovascular diseases in adulthood.
The investigators decided to implement an intervention study in rural communities in the state of Yucatan because this region presents a higher proportion of Maya population than other states of Mexico, but also Yucatan has the highest prevalence of both obesity and undernutrition in children in the country. Previous studies from the investigators group in a Maya child population revealed a frequency of 50% MetS, 34.9% Insulin Resistance (IR), in addition to deficiencies of essential micronutrients. Despite the fact micronutrients are essential for adequate functioning of metabolic processes, few studies in Mexico propose an intervention with enriched food with multiple nutrients such as micronutrients and omega-3 fatty acids. Also, there is little evidence from micronutrient intervention studies in schoolchildren with malnutrition in Mexico, as a strategy to impact on nutritional status and preventive metabolic conditions. For instance, a study by García-López S et al in Mexican schoolchildren with overweight and MetS showed a decrease in lipid and glycemic profiles when supplemented with omega 3-fatty acids for 1 month. Therefore, the present study aimed to evaluate the effect of 4-week intervention with enriched cookies containing a micronutrient formula designed specifically to target the nutritional deficiencies identified in the children. The investigators assessed anthropometric, clinical, biochemical, and cognitive parameters; diet and molecular parameters were assessed only at pre-intervention.
Study location: This study was conducted in three elementary schools of Maya rural communities of Yucatan. The communities are Xocén, Tahmek, and San José Oriente.
Study design: This study was a paired clinical trial. Participants were their own control for the enriched food intervention.
Sample size: The investigators used an equation for finite population. The sample size was estimated to have 80% of statistical power and 95% of a confidence level. A 15% was considered for calculations for dropout during the intervention. Based on the prevalence of malnutrition in Mexico and one community (Xocén), the total number of participants was 106.
Sampling procedure: The investigators considered the inclusion and exclusion criterions. Participants were assigned with the convenience sampling technique.
Intervention: The intervention consisted of a either a handmade oatmeal cookie or industrialized cookies both enriched with a formula FV-UNAM. The handmade oatmeal cookies enriched with the supplement formula were administered to schoolchildren from Xocén. The industrialized cookies, called Globitos, were donated by DONDÉ cookie factory company, and were supplemented with the same formula as the oatmeal cookies. The enriched Globitos were distributed to the schoolchildren from Tahmek and San José Oriente. The FV formula for children was designed by the Facultad de Química-UNAM. The FV formula is in powder form that contains vitamins, minerals, antioxidants, and omega-3 fatty acids, which are nutrients that have been observed to be deficient in the studied schoolchildren populations. The formulation was within the requirements of the Reference Daily Intake (RDI) for the Mexican population, according to their age, from the Official Mexican Standard (NOM)-051-SCFI/SSA1-2010.
Measurements: A nutritional-clinical face-to-face interview was performed with parents or tutors and children. When necessary, assistance from a local translator was used. Nutritional data was collected before pre-intervention. Anthropometric, clinical, biochemical, and cognitive parameters were collected pre- and post-intervention; diet and molecular parameters were assessed only at pre-intervention.
Adverse effects of the enriched cookies. Any adverse effects were assessed during a weekly visit. The information was obtained by teachers, parents or tutors.
Ethics approval. The study protocol was approved by the Ethics Committee of Hospital Juárez de México (HJM2315/14-C).
Data Analysis. Data was analyzed using the Statistical Program for Social Sciences (SPSS), version 20. Descriptive data was shown with tables pre- and post-intervention. Categorical variables were used as percentages. Continuous variables were tested for normality and were presented as mean and standard deviation. To determine significance of observed differences between pre- and post-intervention measurements the investigators used paired t-Student (parametric variables) and Wilcoxon (non-parametric) tests. An ANCOVA was performed to identify correlations between nutritional status and parameters, and was adjusted by age, gender, and BMI-z-score as fixed variables. Logistic regression was used to determine the effects of polymorphism under the risk of metabolic abnormality. A 95% confidence level was used, and a P value <0.05 was considered statistically significant.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
84 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal