Supplementation With PUFA´s in Obese Children

NCT05488223 | Completed DMC

• 1 other identifier: HIM/2013/0001
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Obesity; Insulin Resistance; Metabolic Complication

Keywords

child; obesity; insulin resistance; metabolic profile; PUFA ω-3

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Change in waist circumference (percentile)

  Change in waist circumference percentile from baseline at 3 months

• Change in waist circumference (percentile)

  Change in waist circumference percentile from baseline at 5 months

• Change in metabolic parameters (mg/dL)

  Change in metabolic parameters (mg/dL)from baseline at 3 months

• Change in metabolic parameters (mg/dL)

  Change in metabolic parameters (mg/dL) from baseline at 5 months

• Change in cytokines (pg/mL)

  Change in cytokines (pg/mL) from baseline at 3 months

Study Arms (3)

PUFA ω-3 (1.8g/day)

EXPERIMENTAL

ω-3 PUFAs (Triple Strength Fish Oil®) were purchased in advance, each capsule contained 540 mg of eicosapentaenoic acid (20:5 n-3) and 360 mg of docosahexaenoic acid (22:6 n-3), for a 0.9g total. Children and parents were told that they should take 2 capsules of ω-3 PUFAs daily, that is, they took 1.8g/day. Parents and children were informed that the duration of the study would be 5 months, in the first three months, the children should take the capsules of the assigned treatment; in the fourth and fifth months they should continue their surveillance with the researchers. At the beginning, they were given 2 bottles of 30 capsules each, identified as formula A or B, according to the assigned group, and they were given a calendar sheet indicating that they should cross out a box if they had consumed the breakfast capsule and cross out another box if the consumed during the meal; Likewise, they were asked to write down any adverse effect, if any, on the same sheet.

Dietary Supplement: AGPI ω-3 (Triple Strength Fish Oil®)

PUFAs ω-3 0.9 g/day + MUFAs (avocado oil) 0.9 g/day.

ACTIVE COMPARATOR

A commercial brand of avocado oil (MUFA) was purchased in advance by putting 0.9g in each capsule. The appearance of the ω-3 PUFA capsules and the avocado oil capsules were the same. Then we worked with the company that prepared the blinding of the treatments, packaging bottles of 30 capsules each, labeling them as bottles A and B. The design contemplated giving each child two bottles, one marked to take it for breakfast and another marked to take it with food. The child was instructed to take 1 capsule per day of PUFA ω-3 (0.9g/d) and 1 capsule of avocado oil (0.9g/d)

Dietary Supplement: AGPI ω-3 + MUFA (avocado oil)

MUFAs (avocado oil) 1.8 g/day.

PLACEBO COMPARATOR

The child was instructed to take 2 capsules per day, 1.8g of avocado oil per day.

Dietary Supplement: MUFA (avocado oil) (1.8g)

Interventions

AGPI ω-3 (Triple Strength Fish Oil®) DIETARY_SUPPLEMENT

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.

PUFA ω-3 (1.8g/day)

AGPI ω-3 + MUFA (avocado oil) DIETARY_SUPPLEMENT

AGPI ω-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.

PUFAs ω-3 0.9 g/day + MUFAs (avocado oil) 0.9 g/day.

MUFA (avocado oil) (1.8g) DIETARY_SUPPLEMENT

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.

MUFAs (avocado oil) 1.8 g/day.

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead
• Centro Universitario del Sur, Guadalajara: collaborator
• Instituto de Servicios Descentralizados de Salud Pública del Estado de Campeche: collaborator

Study Sites (1)

Hospital Infantil de México Federico Gómez

Mexico City, 06720, Mexico

Location

Related Publications (3)

• 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.

  PMID: 23438101 RESULT

• 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.

  PMID: 20529295 RESULT

• 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.

  PMID: 25885348 RESULT

Related Links

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

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance; Obesity

Interventions

Fatty Acids, Monounsaturated

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Jenny Vilchis Gil, PhD

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Preparation of the intervention products, to blind the study. ω-3 PUFAs (Triple Strength Fish Oil®) were purchased in advance, each capsule contained 540 mg of eicosapentaenoic acid (20:5 n-3) and 360 mg of docosahexaenoic acid (22:6 n-3), for a 0.9g total. Likewise, a commercial brand of avocado oil (AcAg) was purchased in advance, putting the same amount in each capsule. The appearance of the ω-3 PUFA capsules and the AcAg capsules were the same. Then we worked with the company that prepared the blinding of the treatments, packaging bottles of 30 capsules each, labeling them as bottles A and B. The design contemplated giving each child two bottles, one marked to take it for breakfast and another marked to take it with food. The content of each of the capsules was saved as a code that was unknown to the participants, the care provider, or the researchers. The codes were opened until the end of the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 4, 2022
• Study Start: February 17, 2014
• Primary Completion: December 16, 2015
• Study Completion: September 26, 2016
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: When the study is published, the database will be available in the journal indefinitely.
• Access Criteria: Access to the database through the journal where it is published, in the supplementary files section

Locations

ME (1)