Childhood Obesity Clinical Trial
— COOBAOfficial title:
Effect of Cocoa Flavonols Oral Supplement on Body Composition, Metabolic, Inflammatory and Oxidative Profile in Obese Subject 10 to 16 Years
Verified date | October 2019 |
Source | National Polytechnic Institute, Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 116 |
Est. completion date | November 15, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 16 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Polytechnic Institute, Mexico | Hospital Infantil de Mexico Federico Gomez, Instituto Nacional de Salud Publica, Mexico, Universidad Nacional Autonoma de Mexico |
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Gutiérrez-Salmeán G, Ortiz-Vilchis P, Vacaseydel CM, Rubio-Gayosso I, Meaney E, Villarreal F, Ramírez-Sánchez I, Ceballos G. Acute effects of an oral supplement of (-)-epicatechin on postprandial fat and carbohydrate metabolism in normal and overweight su — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TG / HDL-C ratio | The Triglycerides / High-density lipoprotein cholesterol (TG / HDL-c) index is the most practical atherogenic marker for assessing the presence of cardiometabolic risks. | 3 month | |
Primary | Body Fat Mass (BFM) percentage | Result obtained by dual x-ray absorptiometry | 3 month | |
Primary | Insulin Resistance Homeostasis Evaluation Model (HOMA-IR) | Result obtained from fasting glucose determinations multiplied by fasting insulin determination divided by a constant of 405 | 3 month | |
Secondary | Quantitative determination of HS-PCR, TNF-a, TFG-ß, IL-6 and IL-10 | Result obtained from the quantification by Kits of human inflammatory cytokines by Enzyme Linked Inmuno Sorbent Assay from blood serum. | 3 month | |
Secondary | Determined by the quantification of carbonylated protein | Result obtained from the quantification of absorbance by colorimetry of carbonyl groups of proteins are generated by oxidation of several chains of amino acids, by the adduct formation of the reaction of Michael and glycosylation | 3 month | |
Secondary | Determined by the quantification of Malondialdehyde (MDA) | Result obtained from the quantification of the absorbance by colorimetry of the decomposition of unsaturated lipids that react by the addition from Michael. | 3 month | |
Secondary | Body Mass Index (BMI) | Result obtained from the division body weight and square size | 1 Month | |
Secondary | Indirect Calorimetry | Determined by calculating the respiratory coefficient by measuring the Carbon Dioxide (CO2) produced with respect to the Oxygen (O2) consumed. | 3 month |
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