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Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c

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ClinicalTrials.gov Identifier: NCT00445354
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : February 7, 2019
Sponsor:
Information provided by:
Eglin AFB Regional Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: cinnamon Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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
Actual Study Start Date : March 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. hemoglobin A1c

Secondary Outcome Measures :
  1. diabetes medications

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetics greater tahn 18 years of age

Exclusion Criteria:

  • allergy to cinnamon pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445354


Locations
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United States, Florida
Eglin AFB Regional Hospital
Eglin Air Force Base, Florida, United States, 32542
Sponsors and Collaborators
Eglin AFB Regional Hospital
Investigators
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Principal Investigator: Paul F Crawford, MD Eglin AFB Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00445354    
Other Study ID Numbers: FWH20060194H
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Keywords provided by Eglin AFB Regional Hospital:
cinnamon
diabetes
hemoglobin a1c