Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes

May 26, 2020 updated by: Julio Alfredo Garcia Puga, Universidad de Sonora

Evaluation of the Effect of Cinnamomum Zeylanicum on Glycemic Levels of Mexican Adult Patients With Type 2 Diabetes at 3 Months: Randomized Clinical Trial

Type 2 Diabetes (T2D) is protected against chronic hyperglycemia. This is one of the main causes of death in the country, being a public health problem worldwide. Some studies have shown that herbal products have beneficial effects in patients with diabetes by improving the metabolism of glucose and lipids. Cinnamomum Zeylanicum (C.Z.), colloquially cinnamon, is one of the components of the diet that has active biological substances with insulin mimetic properties. In Mexico, little has been investigated about the use of this therapy. Previous studies do not conclude if there is a statistically significant effect in the glycemic control of patients with diabetes. Therefore, it is proposed to evaluate the effect of the supplement consumption of C.Z. 3 months compared to a control group on the change in glycated hemoglobin (HbA1c) in Mexican adults with T2D. This is a randomized, single-blind clinical trial with T2D patients from the clinic CAAPS . Those that are divided into: intervention group with supplement of 2g daily C.Z. Oral route (capsules) for 90 days, and control group with placebo. The figures will be recorded: HbA1c, fasting plasma glucose, blood pressure, cholesterol, HDL, LDL, triglycerides, waist circumference, weight and body mass index.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cinnamon, in in vitro and in vivo studies, has been shown to have biologically active substances with mimetic properties of insulin. In 1990 an unidentified component of cinnamon was extracted and named as an insulin-enhancing factor. The components of cinnamon bark oil (Ceylon) contain cinnamaldehyde (75%), cinnamyl acetate (5%), caryophyllene (3.3%), linalool (2.4%) and eugenol (2.2%). It is believed that the modality in which cinnamon expresses its effect on blood glucose can be attributed to its active component cinnamaldehyde.

Within the 250 species of the Cinnamomum genus there are four types that are used as spice, the Cinnamomum Zeylanicum or Sri Lanka (also known as C. verum Ceylon) commonly referred to as "true cinnamon"; three very popular spices related to C. cassia are C. aromaticum (cinnamon china), C. loureirii (cinnamon vietnamese) and C. burmanni (cinnamon indonesia).

One important difference between "true cinnamon" and cinnamon cassia is its coumarin content. The content of coumarin in cinnamomum zeylanicum is too low to cause health risks, while the level of coumarin in Cinnamomum aromaticum appears to be much higher and may pose health risks if consumed in larger quantities and on a regular basis. The use of cinnamon cassia as a regular supplement with meals is not recommended or the daily dose has been restricted in many countries due to the toxic effects of Cinnamomum aromaticum on the liver and coagulation. In contrast, cinnamomum zeylanicum has been shown to contain a lower amount of coumarin, and therefore it may be possible to use it at higher doses without toxic effects for longer periods. In vivo studies with cinnamomum zeylanicum have not shown significant adverse effects or toxicity in liver, kidney and / or pancreas.

In a systematic review it was concluded that the evidence available in vitro and in vivo suggests that cinnamomum zeylanicum has antimicrobial, antiparasitic, anti-inflammatory and antioxidant properties. The authors also indicated that cinnamomum zeylanicum appears to lower blood glucose, serum cholesterol, and blood pressure, suggesting beneficial cardiovascular effects.

The mechanism of this hypoglycaemic action is not entirely clear, but can be attributed to an increase in serum insulin levels, storage of liver glycogen, better signaling of the insulin receptor, an insulinomimetic effect, or reduction of alpha activity intestinal -glucosidase. In clinical terms, these actions could lead to improvements in glycemic control and insulin sensitivity, and a possible reduction in the complications of diabetes.

In Mexico, little has been investigated on the use of this alternative therapy. In other countries, such as the United States, the United Kingdom, China, Pakistan and Germany, studies have been conducted on the potential effects of cinnamomum in in vitro, in vivo and in human studies. The effect of C. zeylanicum on glycemic control is inconclusive due to the contradictory results of the literature, some authors found statistically significant changes in glycosylated hemoglobin or fasting plasma glucose in randomized clinical trials compared with a placebo group. On the other hand, several authors report not having found significant changes in glucose levels in the study subjects.

In the case of the Mexican population, no scientific studies were found that address the use of cinnamomum as an alternative therapy-alone or combined-in the control of glycemic levels in patients with diabetes. Therefore, in this study we propose to evaluate the effect of cinnamomum zeylanicum supplement consumption at 3 months compared to a control group (placebo) on the change in HbA1c in Mexican adults with T2D.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Sonora
      • Hermosillo, Sonora, Mexico, 83000
        • C.A.A.P.S.
      • Hermosillo, Sonora, Mexico, 83140
        • ISSSTE Family Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a prior medical diagnosis of T2D
  • Mexican adults (> 18 years)
  • Treatments only with oral hypoglycemic agents
  • HbA1c >6.5% and <10%
  • Attendees to two participating primary health care centers.

Exclusion Criteria:

  • Patients who have an allergy to cinnamon or wheat flour.
  • Treatments with insulin
  • Gastrointestinal problems or any condition in cinnamon is not well tolerated or contraindicated
  • Cardiovascular, hepatic or renal disease.
  • Use of addictive substances as drugs.
  • Pregnant or lactation
  • Psychiatric condition that prevents adherence to treatment
  • Use of a supplement with an effect on glucose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Daily supplement of 2 g cinnamomum zeylanicum orally (capsules) for a period of 90 days
Dietary supplement: Cinnamomum zeylanicum
Capsules of 2 g cinnamomum zeylanicum orally
Placebo Comparator: Control group
Daily placebo capsules orally (wheat flour without any active compound) for a period of 90 days.
Other: Placebo
Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: baseline to 3 months
Change in glycated hemoglobin
baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting plasma glucose
Time Frame: baseline to 3 months
Change in fasting plasma glucose
baseline to 3 months
Total cholesterol
Time Frame: baseline to 3 months
Change in total cholesterol
baseline to 3 months
HDL
Time Frame: baseline to 3 months
Change in HDL Cholesterol
baseline to 3 months
LDL
Time Frame: baseline to 3 months
Change in LDL Cholesterol
baseline to 3 months
Triglycerides
Time Frame: baseline to 3 months
Change in Triglycerides
baseline to 3 months
Weight
Time Frame: baseline to 3 months
Change in Weight
baseline to 3 months
Waist circumference
Time Frame: baseline to 3 months
Change in waist circumference
baseline to 3 months
Body Mass Index
Time Frame: baseline to 3 months
Change in the Body Mass Index
baseline to 3 months
Blood pressure
Time Frame: baseline to 3 months
Change in blood pressure
baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Sonora

Investigators

  • Principal Investigator: Julio Alfredo García Puga, Ph.D., Universidad de Sonora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2019

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

April 23, 2020

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (Actual)

July 17, 2019

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cinnamon-T2D-MEX-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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