Clinical trial NCT05488223: Supplementation With PUFA´s in Obese Children
Official title: Effect of Two Omega 3 Polyunsaturated Fatty Acid Schemes on Insulin Resistance and the Inflammatory and Lipid Profile in Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Insulin Resistance
Metabolic Complication
Keywords: child
obesity
insulin resistance
metabolic profile
PUFA ω-3
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
Collaborators: name: Centro Universitario del Sur, Guadalajara
name: Instituto de Servicios Descentralizados de Salud Pública del Estado de Campeche
First posted: 2022-08-04
Enrollment: 133
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subject to written informed consent, children who agreed to participate were randomly assigned to the following treatment groups. Group 1. Two daily capsules of ω-3FAs; Group 2. Two daily capsules, one of ω-3FAs of 0.9 g + 1 capsule of avocado oil (AcAg) of 0.9 g and; Group 3. Two daily capsules of 0.9 g of AcAg.
Primary purpose: TREATMENT

Brief summary: Introduction. Insulin resistance (IR) accompanies practically half of children with obesity. This alteration is the border between what can be reversible or permanent. Among the comorbidities associated with IR are T2D and cardio and cerebrovascular diseases, which are the leading causes of death in Mexico. It has been said that the prevention of obesity rather than its treatment is the way to contain this problem. It has been proposed to supplement obese children with IR with ω-3 polyunsaturated fatty acids (PUFA) or ω-9 monounsaturated fatty acids (MUFA) to determine their ability to reverse these alterations.

Objetive. To evaluate the effect of supplementing PUFA ω-3, PUFA ω-9 or both, on the change in anthropometric and metabolic parameters in obese children with IR.

Methods. Clinical trial, randomized triple-blind, in which obese children with IR participated. Intervention. Three groups were integrated that received one of the following treatments for three months: Group 1: PUFA ω-3 1.8 g/day; Group 2: PUFA ω-3 0.9 g/day + PUFA ω-9 0.9 g/day (avocado oil). Group 3: MUFA ω-9 1.8 g/day. Tracing. For 2 more months he continued his clinical surveillance. Anthropometric and metabolic profile measurements were made at baseline, 3 and 5 months. Throughout the study, all three child groups received nutritional counseling, but no calorie-restricted diets or exercise programs were used.

Detailed description: Specific objectives

1. To compare between the study groups, the concentrations of glucose, insulin and HOMA-IR Index, at baseline, at the end of supplementation with PUFA ω-3 and PUFA ω-9 (3 months) and 2 months after supplementation. the supplementation.
2. To compare between the study groups, the concentrations of total cholesterol, HDL cholesterol, LDL cholesterol and TG at baseline, at the end of supplementation and 2 months after supplementation.
3. To compare between the study groups the change in the percentile values of body mass index (BMI) and waist circumference (WC), between the study groups, at baseline, at the end of supplementation (3 months) and 2 months after supplementation.

Methods. A randomized, controlled, triple-blind clinical trial was conducted, which included 133 children with obesity (BMI ≥95th percentile) and with IR (HOMA-IR ≥ 3.0).

Eligibility criteria: Inclusion Criteria:

* Children with obesity (BMI ≥95 pc), according to the CDC reference tables.
* HOMA-IR ≥ 3.0.
* That they grant their written consent to participate.

Exclusion Criteria:

* Patients with any chronic disease.
* Patients who consume medications that alter their metabolic profile.

Primary outcomes:
measure: Change in insulin resistance
timeFrame: Change in insulin resistance from baseline at 3 months
measure: Change in insulin resistance
timeFrame: Change in insulin resistance from baseline at 5 months
measure: Change in BMI percentile
timeFrame: Change in BMI percentile from baseline at 3 months
measure: Change in BMI percentile
timeFrame: Change in BMI percentile from baseline at 5 months
Secondary outcomes:
measure: Change in waist circumference (percentile)
timeFrame: Change in waist circumference percentile from baseline at 3 months
measure: Change in waist circumference (percentile)
timeFrame: Change in waist circumference percentile from baseline at 5 months
measure: Change in metabolic parameters (mg/dL)
timeFrame: Change in metabolic parameters (mg/dL)from baseline at 3 months
measure: Change in metabolic parameters (mg/dL)
timeFrame: Change in metabolic parameters (mg/dL) from baseline at 5 months
measure: Change in cytokines (pg/mL)
timeFrame: Change in cytokines (pg/mL) from baseline at 3 months
measure: Change in cytokines (pg/mL)
timeFrame: Change in cytokines (pg/mL) from baseline at 5 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Infantil de México Federico Gómez
Study officials:
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Jenny Vilchis Gil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juarez-Lopez C, Klunder-Klunder M, Madrigal-Azcarate A, Flores-Huerta S. Omega-3 polyunsaturated fatty acids reduce insulin resistance and triglycerides in obese children and adolescents. Pediatr Diabetes. 2013 Aug;14(5):377-83. doi: 10.1111/pedi.12024. Epub 2013 Feb 25.
citation: Juarez-Lopez C, Klunder-Klunder M, Medina-Bravo P, Madrigal-Azcarate A, Mass-Diaz E, Flores-Huerta S. Insulin resistance and its association with the components of the metabolic syndrome among obese children and adolescents. BMC Public Health. 2010 Jun 7;10:318. doi: 10.1186/1471-2458-10-318.
citation: Vilchis-Gil J, Galvan-Portillo M, Klunder-Klunder M, Cruz M, Flores-Huerta S. Food habits, physical activities and sedentary lifestyles of eutrophic and obese school children: a case-control study. BMC Public Health. 2015 Feb 11;15:124. doi: 10.1186/s12889-015-1491-1.