NCT04112251: COOBA

Effects of COcoa Supplement in OBese Adolescent Subjects

Completed NA Last updated 3 April 2026

What this trial tests

NA trial testing Cocoa Flavonols Supplement in Childhood Obesity in 104 participants. Completed in 15 November 2020.

Timeline

15 December 2019

Primary endpoint
1 September 2020

15 November 2020

Quick facts

Lead sponsor	National Polytechnic Institute, Mexico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	104
Start date	15 December 2019
Primary completion	1 September 2020
Estimated completion	15 November 2020
Sites	1 location across Mexico

Drugs / interventions tested

• Cocoa Flavonols Supplement

Conditions studied

• Childhood Obesity — all drugs for Childhood Obesity →
• Adolescent Obesity — all drugs for Adolescent Obesity →

Sponsor

National Polytechnic Institute, Mexico

Who can join

Adults 10 to 16, any sex, with Childhood Obesity or Adolescent Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.