Overweight and Obesity Clinical Trial
Official title:
Evaluation of Nutritional Status in Chimalhuacán Children: Anthropometric, Biochemical, and Molecular Approaches
Verified date | May 2021 |
Source | Universidad Nacional Autonoma de Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | April 12, 2019 |
Est. primary completion date | April 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 10 Years |
Eligibility | Inclusion Criteria: - Children with Maya ethnicity confirmed by having parents and grandparents belonging to the same community, and three generations living in the community. - Children enrolled in 3th and 4th year of elementary school from the same educational center, volunteers, who have the informed consent signed by their parents or tutors, and the assent letter signed by children. - Aged between 8 to 10 years. - Both genders. Exclusion Criteria: - Any child who does not want to participate in the study. - Children whose parents or tutors do not agree to sign the informed consent. - Children who do not sign the assent letter. - Age less than 8 years and older than 11 years. - Children using antihypertensive, hypoglycemic or lipid-lowering medications, as well as those that have a history of a condition affected by glucose metabolism, insulin or that alter body composition (cancer, chronic infections, food allergy). - Under treatment of intake of supplements with vitamins, minerals, antioxidants (<2 months). - Children with alcoholism or smoking. |
Country | Name | City | State |
---|---|---|---|
Mexico | Facultad de Química, Unidad Académica de la UNAM en Yucatán | Mérida | Yucatán |
Lead Sponsor | Collaborator |
---|---|
Marta Alicia Menjivar Iraheta |
Mexico,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of weight from pre-intervention and after 4 weeks of intervention | Kilograms | Pre-intervention and post-intervention at week 4 | |
Primary | Change of height from pre-intervention and after 4 weeks of intervention | Meters | Pre-intervention and post-intervention at week 4 | |
Primary | Change of weight-for-age z-score from pre-intervention and after 4 weeks of intervention | Measurement value of weight will be used to calculate weight-for-age in z-score according to age and sex | Pre-intervention and post-intervention at week 4 | |
Primary | Change of height-for-age z-score from pre-intervention and after 4 weeks of intervention | Measurement value of height will be used to calculate height-for-age in z-score according to age and sex | Pre-intervention and post-intervention at week 4 | |
Primary | Change of Body Mass Index z-score from pre-intervention and after 4 weeks of intervention | Weight and height will be combined to calculate Body Mass Index in kg/m^2. The value of BMI will be reported in BMI-for-age in z-score according to age and sex | Pre-intervention and post-intervention at week 4 | |
Primary | Change of tricipital skinfold percentile from pre-intervention and after 4 weeks of intervention | Tricipital skinfold will be reported in percentile according to age and sex | Pre-intervention and post-intervention at week 4 | |
Primary | Change of bone diameters z-score from pre-intervention and after 4 weeks of intervention | Bone diameters will be reported in z-score according to age and sex | Pre-intervention and post-intervention at week 4 | |
Primary | Change of waist circumference percentile from pre-intervention and after 4 weeks of intervention | Waist circumference will be reported in percentile according to age and sex | Pre-intervention and post-intervention at week 4 | |
Primary | Change of waist-to-height ratio from pre-intervention and after 4 weeks of intervention | Waist circumference height will be used to calculate waist-to-height ratio (WHtR) | Pre-intervention and post-intervention at week 4 | |
Primary | Change of body fat-mass pre-intervention and after 4 weeks of intervention | Percentage | Pre-intervention and post-intervention at week 4 | |
Primary | Change of fat-free-mass pre-intervention and after 4 weeks of intervention | Weight and body fat (converted to kg) will be used to calculate fat-free-mass in kilograms | Pre-intervention and post-intervention at week 4 | |
Primary | Change in Systolic Blood Pressure pre-intervention and after 4 weeks of intervention | Systolic Blood Pressure percentile according to age, sex, and height | Pre-intervention and post-intervention at week 4 | |
Primary | Change of red blood count pre-intervention and after 4 weeks of intervention | cell/microliter | Pre-intervention and post-intervention at week 4 | |
Primary | Change of hemoglobin pre-intervention and after 4 weeks of intervention | grams/deciliter | Pre-intervention and post-intervention at week 4 | |
Primary | Change of hematocrit pre-intervention and after 4 weeks of intervention | Percentage | Pre-intervention and post-intervention at week 4 | |
Primary | Change of platelets pre-intervention and after 4 weeks of intervention | Microliter | Pre-intervention and post-intervention at week 4 | |
Primary | Change of white blood cells count in all cell types pre-intervention and after 4 weeks of intervention | Reported value of neutrophils, eosinophils, lymphocytes, monocytes, and basophils in percentage | Pre-intervention and post-intervention at week 4 | |
Primary | Change of glucose and lipid profile pre-intervention and after 4 weeks of intervention | Glucose in milligrams/deciliter (mg/dL)
Total cholesterol in mg/dL Triglycerides in mg/dL Low-density lipoproteins in mg/dL High-density lipoproteins in mg/dL |
Pre-intervention and post-intervention at week 4 | |
Primary | Change of liver profile pre-intervention and after 4 weeks of intervention | Alanine aminotransferase in Unit/liter (U/L)
Aspartate aminotransferase in U/L |
Pre-intervention and post-intervention at week 4 | |
Primary | Change of blood proteins pre-intervention and after 4 weeks of intervention | Albumin in grams/deciliter (g/dL)
Globulin in g/dL Total amount of albumin and globulin will be used to measure the total protein in g/dL |
Pre-intervention and post-intervention at week 4 | |
Primary | Change in cognitive test pre-intervention and after 4 weeks of intervention | Standardized points of intellectual cognition based by a median of 100 | Pre-intervention and post-intervention at week 4 | |
Secondary | Energy intake | Energy intake will be estimated in kilocalories/day | Pre-intervention, assessed up to 1 day | |
Secondary | Macronutrients intake in grams | Carbohydrate, protein and fat intake will be estimated in grams | Pre-intervention, assessed up to 1 day | |
Secondary | Macronutrients intake in percentage | Carbohydrate, protein, and fat intake will be estimated in percentage | Pre-intervention, assessed up to 1 day | |
Secondary | Micronutrients intake in micrograms | Vitamin A intake will be estimate in micrograms
Selenium intake will be estimated in micrograms |
Pre-intervention, assessed up to 1 day | |
Secondary | Micronutrients intake in milligrams | Vitamin E and vitamin C intake will be estimated in milligrams
Iron, calcium, and zinc will be estimated in milligrams |
Pre-intervention, assessed up to 1 day | |
Secondary | Frequency of food intake | Frequencies of food consumption (Percentages) | Pre-intervention, assessed up to 1 week | |
Secondary | Molecular parameters | Allelic frequencies of each polymorphism of genes (Percentages) | Pre-intervention, assessed up to 1 day |
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