Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c
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|ClinicalTrials.gov Identifier: NCT00445354|
Recruitment Status : Unknown
Verified March 2007 by Eglin AFB Regional Hospital.
Recruitment status was: Recruiting
First Posted : March 9, 2007
Last Update Posted : March 9, 2007
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Drug: cinnamon||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2007|
|Estimated Study Completion Date :||August 2007|
- hemoglobin A1c
- diabetes medications
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
|Contact: Paul Crawford, MDemail@example.com|
|United States, Florida|
|Eglin AFB Regional Hospital||Recruiting|
|Eglin AFB, Florida, United States, 32542|
|Contact: James Whitworth, PhD 850-883-8288 firstname.lastname@example.org|
|Principal Investigator: Paul F Crawford, MD|
|Sub-Investigator: Karen L Weis, PhD|
|Principal Investigator:||Paul F Crawford, MD||Eglin AFB Hospital|