Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c

Diabetes Clinical Trial

Official title:

A Randomized Controlled Clinical Trial Comparing the Effect of 1g of Daily Cinnamon Plus Usual Care to Usual Cre on the Hemoglobin A1c of Uncontrolled Type 2 Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445354
• Other study ID #: FWH20060194H
• Status: Completed
• Phase: Phase 3
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: February 2019
• Source: Eglin AFB Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will randomize diabetics with hemoglobin A1c greater than 7.0 to receive either cinnamon plus usual care or usual care alone. Hemoglobin A1c will be measured at intake and after 90 days.

Description:

As the worldwide incidence of diabetes increases, the search for dietary adjuncts to treat this life-altering disease becomes far ranging. Cinnamon is purported to be a natural insulin sensitizer without any known adverse events. Both in vitro and in vivo animal studies have shown that cinnamon is an insulin sensitizer1. Several compounds within cinnamon have been identified as possible sources of this sensitization process.

To-date, three small randomized trials studying cinnamon in human diabetics have been published. Khan et al. reported that fasting serum glucose could be reduced by 18-29% after 40 days of supplementation with 1, 3, or 6 g of cinnamon (Cinnamomum cassia) in type 2 diabetics. 2 This study had several limitations that included failure to measure hemoglobin A1C, all patients were Pakistani, and no power analysis was documented. Vanschoonbeek, et al.3 report a small RCT of postmenopausal women with well-controlled type 2 diabetes which showed no change in HbA1C or fasting glucose. Once again no power analysis is reported. Mang et al. 4 conducted a RCT of type 2 diabetics treated with aqueous extract of cinnamon for 4 months. They report a 15% decrease in fasting glucose and no change in HbA1C over the duration of this trial. Subjects had HbA1C less than 7% and again no power analysis was included in this study.

This study will address whether cinnamon at the dose of 1g daily in addition to usual care lowers hemoglobin A1c compared to usual care. Power analysis indicates that 63 per group are needed and we will recruit 70 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetics greater tahn 18 years of age

Exclusion Criteria:

• allergy to cinnamon pregnancy

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• cinnamon

Locations

Country	Name	City	State
United States	Eglin AFB Regional Hospital	Eglin Air Force Base	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eglin AFB Regional Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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

Talpur N, Echard B, Ingram C, Bagchi D, Preuss H. Effects of a novel formulation of essential oils on glucose-insulin metabolism in diabetic and hypertensive rats: a pilot study. Diabetes Obes Metab. 2005 Mar;7(2):193-9. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1c
Secondary	diabetes medications