Supplementation With PUFA´s in Obese Children

Hospital Infantil de Mexico Federico Gomez

Status: Completed

Conditions: Metabolic Complication; Insulin Resistance; Child Obesity

Treatments: Dietary Supplement: AGPI ω-3 (Triple Strength Fish Oil®); Dietary Supplement: AGPI ω-3 + MUFA (avocado oil); Dietary Supplement: MUFA (avocado oil) (1.8g)

Study type: Interventional

Funder types: Other

Identifiers

NCT05488223

HIM/2013/0001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 133 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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133 participants in 3 patient groups, including a placebo group

PUFA ω-3 (1.8g/day)

Experimental group

Description:

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.

Treatment:

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 group

Description:

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)

Treatment:

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

MUFAs (avocado oil) 1.8 g/day.

Placebo Comparator group

Description:

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

Treatment:

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