Supplementation With PUFA´s in Obese Children

Insulin Resistance Clinical Trial

— PUFA  

Official title:

Effect of Two Omega 3 Polyunsaturated Fatty Acid Schemes on Insulin Resistance and the Inflammatory and Lipid Profile in Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488223
• Other study ID #: HIM/2013/0001
• Status: Completed
• Phase: N/A
• Start date: February 17, 2014
• Est. completion date: September 26, 2016

Study information

• Verified date: August 2022
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 26, 2016
• Est. primary completion date: December 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Obesity
• Insulin Resistance
• Metabolic Complication
• Pediatric Obesity

Intervention

Dietary Supplement:
• AGPI ?-3 (Triple Strength Fish Oil®)
The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs.
• AGPI ?-3 + MUFA (avocado oil)
AGPI ?-3 (0.9g) + MUFA (avocado oil) (0.9g) The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs.
• MUFA (avocado oil) (1.8g)
MUFA (avocado oil) (1.8g) The children met at a clinical studies office every month for the 5 months, in order to exchange the empty bottles for the full ones and review the consumption record sheet and receive their advice on their diet. In case of absence, the children were located to avoid losses. Finally, at each visit, all the children and their parents received counseling to promote the acquisition of healthy habits related to eating and physical activity, but did not indicate caloric restriction diets or undergo exercise programs.

Locations

Country	Name	City	State
Mexico	Hospital Infantil de México Federico Gómez	Mexico City

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez	Centro Universitario del Sur, Guadalajara, Instituto de Servicios Descentralizados de Salud Pública del Estado de Campeche

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Juárez-López C, Klünder-Klünder M, Madrigal-Azcárate 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. E — View Citation

Juárez-López C, Klünder-Klünder M, Medina-Bravo P, Madrigal-Azcárate A, Mass-Díaz 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; — View Citation

Vilchis-Gil J, Galván-Portillo M, Klünder-Klünder 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/s1288 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin resistance	Insulin concentrations were immunoassayed with MILLIPLEX® MAP, based on automated Luminex xMAP® technology. Luminex that uses microsphere techniques, which are coated with specific capture antibodies, and employs two fluorescent dyes. The bioassay result was quantified based on the fluorescence signals. The data was integrated and analyzed with the MILLIPLEX® Analyst 5.1 software.; The following equation was used to obtain the homeostasis model to assess the index of insulin resistance (HOMA-IR): fasting glucose (mg/dl) x fasting insulin (µU/ml) / 405	Change in insulin resistance from baseline at 3 months
Primary	Change in insulin resistance	Insulin concentrations were immunoassayed with MILLIPLEX® MAP, based on automated Luminex xMAP® technology. Luminex that uses microsphere techniques, which are coated with specific capture antibodies, and employs two fluorescent dyes. The bioassay result was quantified based on the fluorescence signals. The data was integrated and analyzed with the MILLIPLEX® Analyst 5.1 software.; The following equation was used to obtain the homeostasis model to assess the index of insulin resistance (HOMA-IR): fasting glucose (mg/dl) x fasting insulin (µU/ml) / 405	Change in insulin resistance from baseline at 5 months
Primary	Change in BMI percentile	Weight (kg) and height (cm) were taken using internationally accepted procedures and standardized per person. Briefly, weight and height were measured without shoes and in light clothing. Weight was taken with a digital scale (Seca 884, Hamburg, Germany) with a precision of 0.1 kg; height was measured using a stadiometer (Seca 225). With the values of weight, height, age and sex, the BMI percentile was obtained according to the CDC.	Change in BMI percentile from baseline at 3 months
Primary	Change in BMI percentile	Weight (kg) and height (cm) were taken using internationally accepted procedures and standardized per person. Briefly, weight and height were measured without shoes and in light clothing. Weight was taken with a digital scale (Seca 884, Hamburg, Germany) with a precision of 0.1 kg; height was measured using a stadiometer (Seca 225). With the values of weight, height, age and sex, the BMI percentile was obtained according to the CDC.	Change in BMI percentile from baseline at 5 months
Secondary	Change in waist circumference (percentile)	Waist circumference (cm) was measured with the children in a standing position, using a flexible tape measure (Seca 201®), placed at the midpoint between the lower rib and the iliac crest after a normal exhalation, according to the protocol of WHO. Using the tables of waist circumference of Mexican children, a very high risk was considered if the circumference was greater than the 90th percentile	Change in waist circumference percentile from baseline at 3 months
Secondary	Change in waist circumference (percentile)	Waist circumference (cm) was measured with the children in a standing position, using a flexible tape measure (Seca 201®), placed at the midpoint between the lower rib and the iliac crest after a normal exhalation, according to the protocol of WHO. Using the tables of waist circumference of Mexican children, a very high risk was considered if the circumference was greater than the 90th percentile.	Change in waist circumference percentile from baseline at 5 months
Secondary	Change in metabolic parameters (mg/dL)	Glucose (mg/dL), low-density lipoprotein (mg/dL), high-density lipoprotein (mg/dL), triglycerides (mg/dL), and total cholesterol (mg/dL) determinations were analyzed with enzymatic methods according to the procedures manual of the Central Laboratory of the Hospital Infantil de México Federico Gómez (Dimension-RXL, Dade Behring, Germany).	Change in metabolic parameters (mg/dL)from baseline at 3 months
Secondary	Change in metabolic parameters (mg/dL)	Glucose (mg/dL), low-density lipoprotein (mg/dL), high-density lipoprotein (mg/dL), triglycerides (mg/dL), and total cholesterol (mg/dL) determinations were analyzed with enzymatic methods according to the procedures manual of the Central Laboratory of the Hospital Infantil de México Federico Gómez (Dimension-RXL, Dade Behring, Germany).	Change in metabolic parameters (mg/dL) from baseline at 5 months
Secondary	Change in cytokines (pg/mL)	In serum, the following cytokines IL1B, IL4, IL_6, IL10, IFNg, MCP1, TNTa and Leptin (pg/mL) are determined. Based on automated Luminex xMAP® technology.	Change in cytokines (pg/mL) from baseline at 3 months
Secondary	Change in cytokines (pg/mL)	In serum, the following cytokines IL1B, IL4, IL_6, IL10, IFNg, MCP1, TNTa and Leptin (pg/mL) are determined. Based on automated Luminex xMAP® technology.	Change in cytokines (pg/mL) from baseline at 5 months

External Links

•   This page is from the Hospital Infantil de México Federico Gómez where the research protocol was approved and developed.