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Completed

NCT Number: NCT04476160

Effectiveness of Cinnamon on Insulin Resistance ( ECIRCCOS ) December 1, 2019

Childhood obesity is one of the most serious public health problems of the 21st century. It is considered that if there are no changes in prevention and treatment strategies there will be an increase to 70 million obese children by 2025. Of the only pharmacological treatments accepted at this age to improve insulin resistance is metformin, but it can condition gastrointestinal, muscular and hepatic adverse events. Cinnamon is an alternative therapy, which due to its high concentrations of polyphenols, improves insulin resistance by decreasing the proinflammatory environment that occurs in this group of patients, and unlike metformin with less frequent adverse events. The effectiveness of cinnamon has been demonstrated by decreasing insulin resistance in the adult population.

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Key information

Conditions

Obesity, Childhood Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of research in Medical Nutricion, Pediatric Hospital CMN "Siglo XXI" , Instituto Mexicano del Seguro Social, México, México City, Mexico

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About this study

Controlled clinical trial, 100 children aged 10 to 15 years with obesity Body Mass Index (BMI> 2 SD) will be selected. Children and parents who agree to participate will be measured anthropometry (weight, height, BMI, body fat) and Tanner stage. Once the 100 children have been selected and registered, a determination will be made after 8 hours of fasting leptin, ghrelin, insulin, lipid profile, liver function tests, creatinine and cinnamic acid. Subsequently they will be randomly assigned to a group that receives the intervention with cinnamon 3000mg / day, or placebo; Both groups will receive diet and physical activity recommendations according to the World Health Organization (WHO) guidelines. They will be followed for 16 weeks. During this period, patients will be contacted weekly to confirm the consumption of the capsules and interrogation of adverse effects such as dyspepsia, gastrointestinal disturbances and headache. They will be scheduled monthly for capsule counting and interrogation of adverse effects. At the end of the 16-week follow-up, anthropometry, fasting after 8 hours of leptin, ghrelin, insulin lipid profile, liver function tests, creatinine and cinnamic acid will be performed.

Statistical analysis: Shapiro Wilk test will be applied to the variables with quantitative measurement scale to identify the type of distribution; in the case of parametric distribution, the data with averages and standard deviation will be presented, in case of presenting non-parametric distribution, medium and minimum and maximum values will be used. In the case of qualitative variables, they will be expressed with percentages and simple frequencies. Baseline characteristics will be compared between the two groups with t-Student or U-Mann Whitney according to the type of distribution of the variables. To evaluate the effect of the intervention, body fat deltas and biochemical measurements will be calculated by subtracting the final value (after 16 weeks of intervention) from the initial (baseline) value and statistical significance will be evaluated using comparisons between groups with paired t- or Wilcoxon. Covariance analysis control of confounding variables (ANCOVA) will be carried out.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obesity (BMI > 95 percentile )

Exclusion criteria

  • treatment with insulin or Metformin
  • genetic or endocrine obesity
  • routine consumption of cinnamon

Treatment and study plan

Cinnamon

Dietary Supplement

children recipe 3 grams by day of cinnamon

Primary outcomes

  1. homeostatic model assessment (HOMA) index

    Time frame: 16 weeks

    resistence insulin is evaluated for fasting glucose and insulin

  2. Appetite hormone (ghrelin [pg/ml])

    Time frame: 16 weeks

    Change in fasting serum ghrelin from baseline to the end of intervention

  3. Appetite hormone (leptin [ng/ml])

    Time frame: 16 weeks

    Change in fasting serum leptin from baseline to the end of intervention

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: 16 weeks

    change in BMI from baseline to the end of intervention

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Hospital Infantil de Mexico Federico Gomez

Registry information

Official study title

Effectiveness of Cinnamon on Insulin Resistance and Corporate Composition of Obese Schoolchildren

Acronym: ECIRCCOS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2020
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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