Effect of Two Omega 3 Polyunsaturated Fatty Acid Schemes on Insulin Resistance and the Inflammatory and Lipid Profile in Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Change in BMI percentile
研究概览
简要总结
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.
详细描述
Specific objectives
- 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.
- 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.
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with obesity (BMI ≥95 pc), according to the CDC reference tables.
- •HOMA-IR ≥ 3.
- •That they grant their written consent to participate.
排除标准
- •Patients with any chronic disease.
- •Patients who consume medications that alter their metabolic profile.
结局指标
主要结局
Change in BMI percentile
时间窗: Change in BMI percentile from baseline at 5 months
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 insulin resistance
时间窗: Change in insulin resistance from baseline at 5 months
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
次要结局
- 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 5 months)
- Change in cytokines (pg/mL)(Change in cytokines (pg/mL) from baseline at 5 months)
研究者
Jenny Vilchis Gil
Principal Investigator
Hospital Infantil de Mexico Federico Gomez