Effects of COcoa Supplement in OBese Adolescent Subjects

NCT04112251 | Unknown

• 1 other identifier: COOBA-HIM-100
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Childhood Obesity; Adolescent Obesity

Keywords

Childhood Obesity; Cocoa Flavanols; Adolescent Obesity

Outcome Measures

Primary Outcomes (3)

• 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

• Body Fat Mass (BFM) percentage

  Result obtained by dual x-ray absorptiometry

  3 month

• 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 Outcomes (5)

• 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

Study Arms (2)

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.

Dietary Supplement: Cocoa Flavonols Supplement

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.

Dietary Supplement: Cocoa Flavonols Supplement

Interventions

Cocoa Flavonols Supplement DIETARY_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.

Also known as: (-)-epicatechin

Placebo; Supplement

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Polytechnic Institute, Mexico: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Related Publications (14)

• Aceves-Martins M, Llaurado E, Tarro L, Sola R, Giralt M. Obesity-promoting factors in Mexican children and adolescents: challenges and opportunities. Glob Health Action. 2016 Jan 18;9:29625. doi: 10.3402/gha.v9.29625. eCollection 2016.

  PMID: 26787421 RESULT

• Grant-Guimaraes J, Feinstein R, Laber E, Kosoy J. Childhood Overweight and Obesity. Gastroenterol Clin North Am. 2016 Dec;45(4):715-728. doi: 10.1016/j.gtc.2016.07.007.

  PMID: 27837784 RESULT

• Kim J, Lee I, Lim S. Overweight or obesity in children aged 0 to 6 and the risk of adult metabolic syndrome: A systematic review and meta-analysis. J Clin Nurs. 2017 Dec;26(23-24):3869-3880. doi: 10.1111/jocn.13802. Epub 2017 May 23.

  PMID: 28295797 RESULT

• Gupta N, Goel K, Shah P, Misra A. Childhood obesity in developing countries: epidemiology, determinants, and prevention. Endocr Rev. 2012 Feb;33(1):48-70. doi: 10.1210/er.2010-0028. Epub 2012 Jan 12.

  PMID: 22240243 RESULT

• Peneau S, Giudici KV, Gusto G, Goxe D, Lantieri O, Hercberg S, Rolland-Cachera MF. Growth Trajectories of Body Mass Index during Childhood: Associated Factors and Health Outcome at Adulthood. J Pediatr. 2017 Jul;186:64-71.e1. doi: 10.1016/j.jpeds.2017.02.010. Epub 2017 Mar 7.

  PMID: 28283258 RESULT

• Zlatohlavek L, Hubacek JA, Vrablik M, Pejsova H, Lanska V, Ceska R. The Impact of Physical Activity and Dietary Measures on the Biochemical and Anthropometric Parameters in Obese Children. Is There Any Genetic Predisposition? Cent Eur J Public Health. 2015 Nov;23 Suppl:S62-6. doi: 10.21101/cejph.a4191.

  PMID: 26849546 RESULT

• Marseglia L, Manti S, D'Angelo G, Nicotera A, Parisi E, Di Rosa G, Gitto E, Arrigo T. Oxidative stress in obesity: a critical component in human diseases. Int J Mol Sci. 2014 Dec 26;16(1):378-400. doi: 10.3390/ijms16010378.

  PMID: 25548896 RESULT

• Faienza MF, Francavilla R, Goffredo R, Ventura A, Marzano F, Panzarino G, Marinelli G, Cavallo L, Di Bitonto G. Oxidative stress in obesity and metabolic syndrome in children and adolescents. Horm Res Paediatr. 2012;78(3):158-64. doi: 10.1159/000342642. Epub 2012 Oct 10.

  PMID: 23052543 RESULT

• Becker K, Geisler S, Ueberall F, Fuchs D, Gostner JM. Immunomodulatory properties of cacao extracts - potential consequences for medical applications. Front Pharmacol. 2013 Dec 12;4:154. doi: 10.3389/fphar.2013.00154.

  PMID: 24376420 RESULT

• Almoosawi S, Tsang C, Ostertag LM, Fyfe L, Al-Dujaili EA. Differential effect of polyphenol-rich dark chocolate on biomarkers of glucose metabolism and cardiovascular risk factors in healthy, overweight and obese subjects: a randomized clinical trial. Food Funct. 2012 Oct;3(10):1035-43. doi: 10.1039/c2fo30060e. Epub 2012 Jul 16.

  PMID: 22796902 RESULT

• Gutierrez-Salmean G, Ortiz-Vilchis P, Vacaseydel CM, Rubio-Gayosso I, Meaney E, Villarreal F, Ramirez-Sanchez I, Ceballos G. Acute effects of an oral supplement of (-)-epicatechin on postprandial fat and carbohydrate metabolism in normal and overweight subjects. Food Funct. 2014 Mar;5(3):521-7. doi: 10.1039/c3fo60416k.

  PMID: 24458104 RESULT

• Gutierrez-Salmean G, Meaney E, Lanaspa MA, Cicerchi C, Johnson RJ, Dugar S, Taub P, Ramirez-Sanchez I, Villarreal F, Schreiner G, Ceballos G. A randomized, placebo-controlled, double-blind study on the effects of (-)-epicatechin on the triglyceride/HDLc ratio and cardiometabolic profile of subjects with hypertriglyceridemia: Unique in vitro effects. Int J Cardiol. 2016 Nov 15;223:500-506. doi: 10.1016/j.ijcard.2016.08.158. Epub 2016 Aug 8.

  PMID: 27552564 RESULT

• Al-Khudairy L, Loveman E, Colquitt JL, Mead E, Johnson RE, Fraser H, Olajide J, Murphy M, Velho RM, O'Malley C, Azevedo LB, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity and behavioural interventions for the treatment of overweight or obese adolescents aged 12 to 17 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012691. doi: 10.1002/14651858.CD012691.

  PMID: 28639320 RESULT

• Mead E, Brown T, Rees K, Azevedo LB, Whittaker V, Jones D, Olajide J, Mainardi GM, Corpeleijn E, O'Malley C, Beardsmore E, Al-Khudairy L, Baur L, Metzendorf MI, Demaio A, Ells LJ. Diet, physical activity and behavioural interventions for the treatment of overweight or obese children from the age of 6 to 11 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012651. doi: 10.1002/14651858.CD012651.

  PMID: 28639319 RESULT

Related Links

• Worldwide epidemiological data of childhood obesity
• Epidemiological data of childhood obesity in Mexico
• Beneficial effects of a flavanol-enriched cacao beverage on anthropometric and cardiometabolic risk profile in overweight subjects

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Catechin

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: November 15, 2019
• Primary Completion: September 1, 2020
• Study Completion: November 15, 2020
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share