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临床试验/NCT04112251
NCT04112251Unknown不适用

Effect of Cocoa Flavonols Oral Supplement on Body Composition, Metabolic, Inflammatory and Oxidative Profile in Obese Subject 10 to 16 Years

National Polytechnic Institute, Mexico0 个研究点目标入组 116 人开始时间: 2019年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
116
主要终点
Body Fat Mass (BFM) percentage

研究概览

简要总结

Childhood obesity is a serious public health problem internationally. In addition to being associated with the early onset of chronic degenerative diseases such as diabetes, dyslipidemias, coronary artery diseases, among others.

Changes in lifestyle habits are the main axis in the treatment of this disease; however, low adherence to these changes are reflected in the increase in their incidence and prevalence.

There is diverse evidence that the use of flavonoids from cocoa such as (-) - epicatechin are able to prevent cardiovascular risks, decrease insulin resistance, mean arterial pressure, control the lipid profile; mediate oxidative stress, improve mitochondrial function and regulate the inflammatory process in patients with heart failure and diabetes mellitus. Therefore, our working hypothesis is the administration of the oral supplement of flavonoids from cocoa for 12 weeks will be able to reduce the percentage of body fat, improve the metabolic profile and regulate inflammatory and oxidative processes in obese patients 10-16 years, compared to those patients who only take a usual therapy consisting of recommendations of healthy diet and physical activity.

For this, a randomized, double-blind, placebo-controlled clinical trial will be carried out, which will be carried out at the Federico Gómez Children's Hospital of Mexico, during the period from October 2019 to October 2020; with obese patients from 10 to 16 years distributed homogeneously at random in two groups: the control group (Placebo) and the intervention group (Flavonoids from cocoa) both groups affected for 12 weeks.

The variables studied will be: percentage of muscle mass, percentage of fat, body mass index (BMI), waist circumference (CC), fasting glucose, fasting insulin, lipid profile (Total cholesterol, Triglycerides, HDL-c, LDL -c, Ratio TG / HDL-c, High Sensitivity C-Reactive Protein (HS-CRP), Interleukins (IL-6, IL-10), Tumor Growth Factor beta (TGF-β) and Tumoral Necrosis Factor alpha (TNF-α), carbonylated proteins, Malondialdehyde (MDA), indirect calorimetry by respiratory coefficient and treatment adherence.

详细描述

Childhood obesity is global health problem, due to the constant increase in its incidence and prevalence. Having this disease helps increase the costs of care for Chronic Noncommunicable Diseases. The increase in its prevalence since 1975 from 1% to 6% (girls) and 8% (boys) in 2016 between the ranges of 5 to 19 years.

Mexico, occupies the first place worldwide in childhood obesity, only by data from National Health and Nutrition Survey 2016 , it is considered that approximately 3 out of 10 children, 4 out of 10 adolescents present this health problem; the population with the highest health risk being ages between 10 and 17 years. In 2016, the prevalence of obesity in the population between 5 and 11 years old was 15.3% and in adolescents between 12 and 19 years old it was 13.9% .

Although, the scientific evidence has focused on studying different strategies for the prevention, control and treatment of childhood obesity complications; The prevalence of this has not yet been reduced or controlled favorably. It has been demonstrated through meta-analysis and randomized clinical trials that the use of flavonoids from cocoa, such as epicatechin at a concentration of 50 mg to 100 mg / day for 6 to 18 weeks, may decrease the risk of cardiovascular and metabolic diseases, Because it reduces: insulin resistance, diastolic blood pressure, triglycerides, LDL-c and increased HDL-c. These biological effects are related to the antioxidant capacity (inhibition of Nicotinamide adenine dinucleotide phosphate oxidase (NAHPH) and increase of endothelial Nitric Oxide Synthase (eNOS), protein interaction and cell signaling that these compounds have (inhibition of Tumoral Necrosis Factor alpha (TNF-α) and Necrosis Factor beta (NF-β); MAPK pathway regulation ) and finally by the regulation of the inflammatory process through the modulation of the pro-inflammatory elements (Decrease of Il-6, TNF-α and PCR-HS), so it is attractive to establish it as an alternative treatment to reduce the risk of generate comorbidities This research aims to solve the following question: What is the effect of oral supplementation of flavonoids from cocoa on body composition, metabolic, inflammatory and oxidative profile in obese patients 10-16 years old?

This work aims to demonstrate the effect of oral supplementation of flavonoids from cocoa on body composition, anthropometric parameters, biochemical, inflammatory and oxidative markers in obese patients in order to reduce the risk of suffering from other comorbidities, such as metabolic syndrome. , diabetes, high blood pressure and cardiovascular diseases.

From this study the investigators can know the effectiveness of the use of flavonoids from cocoa as epicatechin in a child population and demonstrate the regulatory effect of epicatechin on lipids, inflammation and oxidation. The results obtained from this research will provide us with the necessary evidence to propose whether the use of these flavonoids to prevent the occurrence of other comorbidities of childhood obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

For the implementation of the intervention, they are masked by means of the following measures:

  1. The organoleptic characteristics of the interventions will be the same in color, smell, taste, texture, consistency, weight and size.
  2. The primary container will be the same size, and will contain 65 capsules, which will be identified by means of a code.
  3. The delivery of the treatment will be carried out by a collaborator who is not directly related to the research project, which will be assigned by the Hospital's clinical epidemiology area, according to the randomization list sent by the Integral Cardiometabolic Research Laboratory of the Polytechnic Institute National, in a sealed security envelope.
  4. No direct participant should adjust the dose of the treatment, during the follow-up they will only verify the attachment of the intervention based on the capsule count, collection of anecdotes and direct interview.

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients 10 to 16 years old.
  • Patients who do not take any pharmacological treatment for chronic conditions.
  • Have the signed informed consent and assent.
  • Only the participation of one research subject per family will be accepted.

排除标准

  • Carrying diseases that can alter body weight (endocrine, hematological, immunological, neurological, psychiatric, genetic alterations).
  • Presence of mental retardation and other chronic diseases.
  • That they receive medications that can affect weight, lipid and carbohydrate metabolism.
  • That you are actively participating in some other research protocol.
  • Do not have a body limb.

研究组 & 干预措施

Supplement

Experimental

This group will receive the usual therapy of the endocrinology service, dietary recommendations, physical activity recommendations and the administration of a 500 mg capsule every 12 hours (100 mg / day of epicatechin) for 12 weeks.

干预措施: Cocoa Flavonols Supplement (Dietary Supplement)

Placebo

Placebo Comparator

This group will receive the usual therapy of the endocrinology service, dietary recommendations, physical activity recommendations and the administration of a 500 mg oral placebo capsule (Cornstarch) every 12 hours for 12 weeks.

干预措施: Cocoa Flavonols Supplement (Dietary Supplement)

结局指标

主要结局

Body Fat Mass (BFM) percentage

时间窗: 3 month

Result obtained by dual x-ray absorptiometry

TG / HDL-C ratio

时间窗: 3 month

The Triglycerides / High-density lipoprotein cholesterol (TG / HDL-c) index is the most practical atherogenic marker for assessing the presence of cardiometabolic risks.

Insulin Resistance Homeostasis Evaluation Model (HOMA-IR)

时间窗: 3 month

Result obtained from fasting glucose determinations multiplied by fasting insulin determination divided by a constant of 405

次要结局

  • Quantitative determination of HS-PCR, TNF-α, TFG-β, IL-6 and IL-10(3 month)
  • Determined by the quantification of carbonylated protein(3 month)
  • Determined by the quantification of Malondialdehyde (MDA)(3 month)
  • Body Mass Index (BMI)(1 Month)
  • Indirect Calorimetry(3 month)

研究者

发起方
National Polytechnic Institute, Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo Ceballos Reyes

Researcher

National Polytechnic Institute, Mexico

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