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

NCT04476160 | Completed DMC

• 1 other identifier: R-2018-785-108
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity, Childhood; Insulin Resistance; Insulin Sensitivity

Outcome Measures

Primary Outcomes (3)

• homeostatic model assessment (HOMA) index

  resistence insulin is evaluated for fasting glucose and insulin

  16 weeks

• Appetite hormone (ghrelin [pg/ml])

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

  16 weeks

• Appetite hormone (leptin [ng/ml])

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

  16 weeks

Secondary Outcomes (1)

• Body mass index (BMI)

  16 weeks

Study Arms (2)

Cinnamon

EXPERIMENTAL

In this group, children will receive an intervention with 3000mg / day cinnamon along with diet and physical activity recommendations according to the WHO guidelines. They will be followed for 16 weeks. During this period, patients will be contacted weekly to corroborate 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.

Dietary Supplement: Cinnamon

Control

NO INTERVENTION

In this group, children will receive a placebo intervention along with diet and physical activity recommendations according to the WHO guidelines. They will be followed for 16 weeks. During this period, patients will be contacted weekly to corroborate 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.

Interventions

Cinnamon DIETARY_SUPPLEMENT

children recipe 3 grams by day of cinnamon

Cinnamon

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• obesity (BMI \> 95 percentile )

You may not qualify if:

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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator

Study Sites (2)

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

México, México City, 06720, Mexico

Location

Instituto Mexicano del Seguro Social

Mexico City, Mexico

Location

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessie Nallelly Zurita Cruz

  Coordinación de Investigación en Salud, México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: July 17, 2020
• Study Start: November 12, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 27, 2025

Record last verified: 2020-07

Locations

ME (2)