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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023539
• Other study ID #: Cinnamon-T2D-MEX-2019
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: April 23, 2020

Study information

• Verified date: May 2020
• Source: Universidad de Sonora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 23, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Cinnamomum zeylanicum
Capsules of 2 g cinnamomum zeylanicum orally

Other:
• Placebo
Placebo capsules

Locations

Country	Name	City	State
Mexico	C.A.A.P.S.	Hermosillo	Sonora
Mexico	ISSSTE Family Medicine Clinic	Hermosillo	Sonora

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Sonora

Country where clinical trial is conducted

Mexico, 

References & Publications (20)

Akilen R, Tsiami A, Devendra D, Robinson N. Glycated haemoglobin and blood pressure-lowering effect of cinnamon in multi-ethnic Type 2 diabetic patients in the UK: a randomized, placebo-controlled, double-blind clinical trial. Diabet Med. 2010 Oct;27(10):1159-67. doi: 10.1111/j.1464-5491.2010.03079.x. — View Citation

Allen RW, Schwartzman E, Baker WL, Coleman CI, Phung OJ. Cinnamon use in type 2 diabetes: an updated systematic review and meta-analysis. Ann Fam Med. 2013 Sep-Oct;11(5):452-9. doi: 10.1370/afm.1517. Review. — View Citation

Blevins SM, Leyva MJ, Brown J, Wright J, Scofield RH, Aston CE. Effect of cinnamon on glucose and lipid levels in non insulin-dependent type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2236-7. Epub 2007 Jun 11. — View Citation

Costello RB, Dwyer JT, Saldanha L, Bailey RL, Merkel J, Wambogo E. Do Cinnamon Supplements Have a Role in Glycemic Control in Type 2 Diabetes? A Narrative Review. J Acad Nutr Diet. 2016 Nov;116(11):1794-1802. doi: 10.1016/j.jand.2016.07.015. Epub 2016 Sep 8. Review. — View Citation

Crawford P. Effectiveness of cinnamon for lowering hemoglobin A1C in patients with type 2 diabetes: a randomized, controlled trial. J Am Board Fam Med. 2009 Sep-Oct;22(5):507-12. doi: 10.3122/jabfm.2009.05.080093. — View Citation

Khan A, Safdar M, Ali Khan MM, Khattak KN, Anderson RA. Cinnamon improves glucose and lipids of people with type 2 diabetes. Diabetes Care. 2003 Dec;26(12):3215-8. — View Citation

Khan R, Khan Z, Hussain Shah S. Cinnamon May Reduce Glucose, Lipid and Cholesterol Level in Type 2 Diabetic Individuals. Pakistan J Nutr. 2010;9(5):430-3

Leach MJ, Kumar S. Cinnamon for diabetes mellitus. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007170. doi: 10.1002/14651858.CD007170.pub2. Review. — View Citation

Lu T, Sheng H, Wu J, Cheng Y, Zhu J, Chen Y. Cinnamon extract improves fasting blood glucose and glycosylated hemoglobin level in Chinese patients with type 2 diabetes. Nutr Res. 2012 Jun;32(6):408-12. doi: 10.1016/j.nutres.2012.05.003. Epub 2012 Jun 14. — View Citation

Lungarini S, Aureli F, Coni E. Coumarin and cinnamaldehyde in cinnamon marketed in Italy: a natural chemical hazard? Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008 Nov;25(11):1297-305. doi: 10.1080/02652030802105274. — View Citation

Mang B, Wolters M, Schmitt B, Kelb K, Lichtinghagen R, Stichtenoth DO, Hahn A. Effects of a cinnamon extract on plasma glucose, HbA, and serum lipids in diabetes mellitus type 2. Eur J Clin Invest. 2006 May;36(5):340-4. — View Citation

Mirfeizi M, Mehdizadeh Tourzani Z, Mirfeizi SZ, Asghari Jafarabadi M, Rezvani HR, Afzali M. Controlling type 2 diabetes mellitus with herbal medicines: A triple-blind randomized clinical trial of efficacy and safety. J Diabetes. 2016 Sep;8(5):647-56. doi: 10.1111/1753-0407.12342. Epub 2015 Dec 1. — View Citation

Ranasinghe P, Jayawardena R, Pigera S, Wathurapatha WS, Weeratunga HD, Premakumara GAS, Katulanda P, Constantine GR, Galappaththy P. Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial. BMC Complement Altern Med. 2017 Dec 28;17(1):550. doi: 10.1186/s12906-017-2067-7. — View Citation

Ranasinghe P, Perera S, Gunatilake M, Abeywardene E, Gunapala N, Premakumara S, Perera K, Lokuhetty D, Katulanda P. Effects of Cinnamomum zeylanicum (Ceylon cinnamon) on blood glucose and lipids in a diabetic and healthy rat model. Pharmacognosy Res. 2012 Apr;4(2):73-9. doi: 10.4103/0974-8490.94719. — View Citation

Ranasinghe P, Pigera S, Premakumara GA, Galappaththy P, Constantine GR, Katulanda P. Medicinal properties of 'true' cinnamon (Cinnamomum zeylanicum): a systematic review. BMC Complement Altern Med. 2013 Oct 22;13:275. doi: 10.1186/1472-6882-13-275. Review. — View Citation

Sangal A. Role of cinnamon as beneficial antidiabetic food adjunct: A review. Advaces in Applied Science Research. 2010;2(4):440-50

Sharma P, Sharma S, Agrawal RP, Agrawal V, Singhal S. A randomised double blind placebo control trial of cinnamon supplementation on glycemic control and lipid profile in type 2 diabetes mellitus. Aust J Herbal Med. 2012;24(1):52-7.

Suppapitiporn S, Kanpaksi N, Suppapitiporn S. The effect of cinnamon cassia powder in type 2 diabetes mellitus. J Med Assoc Thai. 2006 Sep;89 Suppl 3:S200-5. — View Citation

Vafa M, Mohammadi F, Shidfar F, Sormaghi MS, Heidari I, Golestan B, Amiri F. Effects of cinnamon consumption on glycemic status, lipid profile and body composition in type 2 diabetic patients. Int J Prev Med. 2012 Aug;3(8):531-6. — View Citation

Vanschoonbeek K, Thomassen BJ, Senden JM, Wodzig WK, van Loon LJ. Cinnamon supplementation does not improve glycemic control in postmenopausal type 2 diabetes patients. J Nutr. 2006 Apr;136(4):977-80. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin	Change in glycated hemoglobin	baseline to 3 months
Secondary	Fasting plasma glucose	Change in fasting plasma glucose	baseline to 3 months
Secondary	Total cholesterol	Change in total cholesterol	baseline to 3 months
Secondary	HDL	Change in HDL Cholesterol	baseline to 3 months
Secondary	LDL	Change in LDL Cholesterol	baseline to 3 months
Secondary	Triglycerides	Change in Triglycerides	baseline to 3 months
Secondary	Weight	Change in Weight	baseline to 3 months
Secondary	Waist circumference	Change in waist circumference	baseline to 3 months
Secondary	Body Mass Index	Change in the Body Mass Index	baseline to 3 months
Secondary	Blood pressure	Change in blood pressure	baseline to 3 months