Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c

NCT ID: NCT00445354

Last Updated: 2019-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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cinnamon

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetics greater tahn 18 years of age

Exclusion Criteria

* allergy to cinnamon pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eglin AFB Regional Hospital

FED

Sponsor Role lead

Principal Investigators

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Paul F Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

Eglin AFB Hospital

Locations

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Eglin AFB Regional Hospital

Eglin Air Force Base, Florida, United States

Site Status

Countries

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United States

References

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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. doi: 10.1111/j.1463-1326.2004.00386.x.

Reference Type BACKGROUND
PMID: 15715893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14633804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16549460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16634838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19734396 (View on PubMed)

Other Identifiers

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FWH20060194H

Identifier Type: -

Identifier Source: org_study_id

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