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Effects of COcoa Supplement in OBese Adolescent Subjects (COOBA)

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ClinicalTrials.gov Identifier: NCT04112251
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborators:
Hospital Infantil de Mexico Federico Gomez
Instituto Nacional de Salud Publica, Mexico
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Guillermo Ceballos Reyes, National Polytechnic Institute, Mexico

Brief 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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Adolescent Obesity Dietary Supplement: Cocoa Flavonols Supplement Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, placebo-controlled clinical trial will be conducted, which will be conducted at the Federico Gómez Children's Hospital in Mexico, during the period from October 2019 to October 2020; with patients with exogenous obesity from 10 to 16 years.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

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.
Primary Purpose: Treatment
Official Title: Effect of Cocoa Flavonols Oral Supplement on Body Composition, Metabolic, Inflammatory and Oxidative Profile in Obese Subject 10 to 16 Years
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
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.
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.
Other Name: (-)-epicatechin

Experimental: Supplement
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.
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.
Other Name: (-)-epicatechin




Primary Outcome Measures :
  1. TG / HDL-C ratio [ Time Frame: 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.

  2. Body Fat Mass (BFM) percentage [ Time Frame: 3 month ]
    Result obtained by dual x-ray absorptiometry

  3. Insulin Resistance Homeostasis Evaluation Model (HOMA-IR) [ Time Frame: 3 month ]
    Result obtained from fasting glucose determinations multiplied by fasting insulin determination divided by a constant of 405


Secondary Outcome Measures :
  1. Quantitative determination of HS-PCR, TNF-α, TFG-β, IL-6 and IL-10 [ Time Frame: 3 month ]
    Result obtained from the quantification by Kits of human inflammatory cytokines by Enzyme Linked Inmuno Sorbent Assay from blood serum.

  2. Determined by the quantification of carbonylated protein [ Time Frame: 3 month ]
    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. Determined by the quantification of Malondialdehyde (MDA) [ Time Frame: 3 month ]
    Result obtained from the quantification of the absorbance by colorimetry of the decomposition of unsaturated lipids that react by the addition from Michael.

  4. Body Mass Index (BMI) [ Time Frame: 1 Month ]
    Result obtained from the division body weight and square size

  5. Indirect Calorimetry [ Time Frame: 3 month ]
    Determined by calculating the respiratory coefficient by measuring the Carbon Dioxide (CO2) produced with respect to the Oxygen (O2) consumed.



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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Additional Information:
Publications of Results:

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Responsible Party: Guillermo Ceballos Reyes, Researcher, National Polytechnic Institute, Mexico
ClinicalTrials.gov Identifier: NCT04112251     History of Changes
Other Study ID Numbers: COOBA-HIM-100
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guillermo Ceballos Reyes, National Polytechnic Institute, Mexico:
Childhood Obesity
Cocoa Flavanols
Adolescent Obesity
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms