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

NCT04023539 | Completed

• 1 other identifier: Cinnamon-T2D-MEX-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Cinnamon; Type 2 diabetes; Diabetes; México; Cinnamomum zeylanicum; Randomized Controlled Trial; Glycated hemoglobin; Glucose control

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin

  Change in glycated hemoglobin

  baseline to 3 months

Secondary Outcomes (9)

• Fasting plasma glucose

  baseline to 3 months

• Total cholesterol

  baseline to 3 months

• HDL

  baseline to 3 months

• LDL

  baseline to 3 months

• Triglycerides

  baseline to 3 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Daily supplement of 2 g cinnamomum zeylanicum orally (capsules) for a period of 90 days

Dietary Supplement: Cinnamomum zeylanicum

Control group

PLACEBO COMPARATOR

Daily placebo capsules orally (wheat flour without any active compound) for a period of 90 days.

Other: Placebo

Interventions

Cinnamomum zeylanicum DIETARY_SUPPLEMENT

Capsules of 2 g cinnamomum zeylanicum orally

Intervention group

Placebo OTHER

Placebo capsules

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (2)

C.A.A.P.S.

Hermosillo, Sonora, 83000, Mexico

Location

ISSSTE Family Medicine Clinic

Hermosillo, Sonora, 83140, Mexico

Location

Related Publications (20)

• 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.

  PMID: 22518078 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24019277 BACKGROUND

• 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.

  PMID: 27618575 BACKGROUND

• 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.

  PMID: 19680836 BACKGROUND

• 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.

  PMID: 29282046 BACKGROUND

• 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.

  PMID: 24148965 BACKGROUND

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

  PMID: 22972104 BACKGROUND

• 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.

  PMID: 20854384 BACKGROUND

• 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. doi: 10.2337/diacare.26.12.3215.

  PMID: 14633804 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22749176 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1111/j.1365-2362.2006.01629.x.

  PMID: 16634838 BACKGROUND

• 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.

  PMID: 19734396 BACKGROUND

• 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. doi: 10.2337/dc07-0098. Epub 2007 Jun 11. No abstract available.

  PMID: 17563345 BACKGROUND

• 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.

  PMID: 26362826 BACKGROUND

• 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.

  PMID: 17718288 BACKGROUND

• 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.

  PMID: 22973482 BACKGROUND

• 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. doi: 10.1093/jn/136.4.977.

  PMID: 16549460 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Julio Alfredo García Puga, Ph.D.

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A simple blinding (participants blinded to the belonging group). The person who will randomize the participants will not be involved in the recruitment of participants. This will be done when we have the total sample of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial This is a simple blind randomized clinical trial with patients with type 2 diabetes, the subjects will be divided into two groups, the intervention supplemented with 2 g daily of cinnamomum zeylanicum orally (capsules) and the control group with a placebo. There will be a follow-up of 3 months every two weeks to measure the variables of interest in the study.

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: September 4, 2019
• Primary Completion: March 20, 2020
• Study Completion: April 23, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)