Supplementation With PUFA´s in Obese Children

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

Interventions

DIETARY_SUPPLEMENT

AGPI ω-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.

DIETARY_SUPPLEMENT

AGPI ω-3 + MUFA (avocado oil)

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Centro Universitario del Sur, Guadalajara

  collaborator UNKNOWN

• Instituto de Servicios Descentralizados de Salud Pública del Estado de Campeche

  collaborator UNKNOWN

• Hospital Infantil de Mexico Federico Gomez

  lead OTHER

Principal Investigators

• Jenny Vilchis Gil, PhD · Hospital Infantil de Mexico Federico Gomez

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

8 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-02-17

Primary Completion

2015-12-16

Completion

2016-09-26

Countries

• Mexico

Study Locations