Supplementation With PUFA´s in Obese Children
Condition: Child Obesity; Insulin Resistance; Metabolic Complication
MeSH terms: Insulin Resistance; Pediatric Obesity
Study type: Interventional

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).
    

Intervention name(s): AGPI ω-3 (Triple Strength Fish Oil®); AGPI ω-3 + MUFA (avocado oil); MUFA (avocado oil) (1.8g)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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 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.; 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.
Allocation: Randomized
Intervention model: Single Group Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: child; obesity; insulin resistance; metabolic profile; PUFA ω-3