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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04112251
Other study ID # COOBA-HIM-100
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date November 15, 2020

Study information

Verified date October 2019
Source National Polytechnic Institute, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Dietary Supplement:
Cocoa Flavonols Supplement
Whose total capsule content of 500 mg of cocoa flavonoids, 50 mg correspond to (-) - epicatechin per capsule, with a total dose of this compound being 100 mg/day.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
National Polytechnic Institute, Mexico Hospital Infantil de Mexico Federico Gomez, Instituto Nacional de Salud Publica, Mexico, Universidad Nacional Autonoma de Mexico

References & Publications (14)

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Outcome

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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