Intervention in Children With Malnutrition

NCT04915638 | Completed

• 1 other identifier: HJM2315/14-C
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity; Stunted Growth; Malnutrition, Child; Nutrient Deficiency

Keywords

Double burden of malnutrition; Enriched food; Micronutrients

Outcome Measures

Primary Outcomes (21)

• Change of weight from pre-intervention and after 4 weeks of intervention

  Kilograms

  Pre-intervention and post-intervention at week 4

• Change of height from pre-intervention and after 4 weeks of intervention

  Meters

  Pre-intervention and post-intervention at week 4

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change of body fat-mass pre-intervention and after 4 weeks of intervention

  Percentage

  Pre-intervention and post-intervention at week 4

• 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

• 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

• Change of red blood count pre-intervention and after 4 weeks of intervention

  cell/microliter

  Pre-intervention and post-intervention at week 4

• Change of hemoglobin pre-intervention and after 4 weeks of intervention

  grams/deciliter

  Pre-intervention and post-intervention at week 4

• Change of hematocrit pre-intervention and after 4 weeks of intervention

  Percentage

  Pre-intervention and post-intervention at week 4

• Change of platelets pre-intervention and after 4 weeks of intervention

  Microliter

  Pre-intervention and post-intervention at week 4

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Energy intake

  Pre-intervention, assessed up to 1 day

• Macronutrients intake in grams

  Pre-intervention, assessed up to 1 day

• Macronutrients intake in percentage

  Pre-intervention, assessed up to 1 day

• Micronutrients intake in micrograms

  Pre-intervention, assessed up to 1 day

• Micronutrients intake in milligrams

  Pre-intervention, assessed up to 1 day

Study Arms (1)

Intervention group

EXPERIMENTAL

Schoolchildren received enriched cookies containing a multiple micronutrients formula. Enriched cookies (20g) with a daily dose of 0.33g of organic mix formula were given in the morning during 4-weeks. The formulation is an industrial secret of UNAM.

Dietary Supplement: Experimental intervention group with enriched cookies

Interventions

Experimental intervention group with enriched cookies DIETARY_SUPPLEMENT

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

Intervention group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marta Alicia Menjivar Iraheta: lead

Study Sites (1)

Facultad de Química, Unidad Académica de la UNAM en Yucatán

Mérida, Yucatán, 97302, Mexico

Location

Related Publications (23)

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• Tam E, Keats EC, Rind F, Das JK, Bhutta AZA. Micronutrient Supplementation and Fortification Interventions on Health and Development Outcomes among Children Under-Five in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis. Nutrients. 2020 Jan 21;12(2):289. doi: 10.3390/nu12020289.

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• Lara-Riegos JC, Ortiz-Lopez MG, Pena-Espinoza BI, Montufar-Robles I, Pena-Rico MA, Sanchez-Pozos K, Granados-Silvestre MA, Menjivar M. Diabetes susceptibility in Mayas: Evidence for the involvement of polymorphisms in HHEX, HNF4alpha, KCNJ11, PPARgamma, CDKN2A/2B, SLC30A8, CDC123/CAMK1D, TCF7L2, ABCA1 and SLC16A11 genes. Gene. 2015 Jul 1;565(1):68-75. doi: 10.1016/j.gene.2015.03.065. Epub 2015 Mar 31.

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Growth Disorders; Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Marta Menjivar, PhD

  Facultad de Química, UNAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Profesor Titular "C" de TC Definitivo

Model Details: The intervention consisted of enriched cookies given to children at school for one month. The intervention included two stages. First stage, schoolchildren received placebo cookies (20g of cookies without formula) each day (Monday to Friday) in the morning for 4 weeks. Then, in the second stage, schoolchildren received enriched cookies (20g with a formula FV-UNAM) each day (Monday to Friday) in the morning for 4 weeks. The formula was added to the cookies in a daily dose of 0.33g of organic mix that contained two vitamins, four minerals and omega-3 fatty acids. The exact composition of the formula is a trade secret held by UNAM. Schoolchildren were their own controls because the study was a paired study. In both stages we collected venous blood and anthropometric, blood pressure, and cognitive measurements before the placebo intervention, after 4 weeks from the beginning of formula intervention and post- intervention.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 7, 2021
• Study Start: February 15, 2018
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)