The Anti-Diabetic and Cholesterol-Lowering Effects of Cinnamon and Cassia Bark
NCT ID: NCT00479973
Last Updated: 2007-11-20
Study Results
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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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2007-09-30
2008-05-31
Brief Summary
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Objective: To determine if the combination common and cassia cinnamon product Cinnamonforce™ (Cinnamomum verum and C. aromaticum) reduces fasting blood glucose, insulin, glycosylated hemoglobin (HA1C), triglyceride, total cholesterol, HDL cholesterol and LDL cholesterol levels in people with type 2 diabetes.
Methodology: Seventy (70) type 2 diabetic participants will be randomized to receive either 140 mg of Cinnamonforce twice daily or placebo over 12 weeks. Physical and laboratory measurements will be taken at baseline, 2 weeks, 4 weeks, 8 weeks and at the end of the trial, 13 weeks.
Results: The differences in the measurements obtained from the group receiving Cinnamonforce and the placebo group will be analyzed and discussed.
Detailed Description
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The primary objective measures will consist of fasting blood glucose, insulin and HA1C. Secondary biochemical measures will include a lipid panel (total cholesterol,triglycerides, HDL and LDL). Other secondary objective measures will consist of blood pressure, weight, body mass index (BMI), waist/hip measurements, patient self-monitoring of blood glucose and homeostasis model assessment of insulin resistance (HOMA-IR) calculations. Liver and kidney toxicity of the intervention will be assessed through serum measurements of a liver panel (AST, ALT, total protein, albumin, alkaline phosphatase, total bilirubin and direct bilirubin), creatinine and blood-urea-nitrogen (BUN). Coagulability effects will be measured (PT, PTT, fibrinogen). Subjective tolerability of the treatment and reported adverse effects will also be included as secondary outcomes. Another secondary outcome will consist of subjective scores from self-reported questionnaires,i.e. Diabetes-39, SF-36.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cinnamonforce
Cinnamonforce™ is a proprietary blend of Cinnamomum aromaticum and Cinnamomum verum bark containing 47 mg of hydroethanolic extract (min. 8% total phenolics) and 23 mg supercritical extract (min. 35% cinnamaldehyde) per capsule.
Cinnamonforce
Cinnamonforce™ is a proprietary blend of Cinnamomum aromaticum and Cinnamomum verum bark containing 47 mg of hydroethanolic extract (min. 8% total phenolics) and 23 mg supercritical extract (min. 35% cinnamaldehyde) per capsule.
2 capsules after the two largest meals of the day
Placebo
Placebo
Placebo. 2 capsules after the two largest meals of the day
Interventions
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Cinnamonforce
Cinnamonforce™ is a proprietary blend of Cinnamomum aromaticum and Cinnamomum verum bark containing 47 mg of hydroethanolic extract (min. 8% total phenolics) and 23 mg supercritical extract (min. 35% cinnamaldehyde) per capsule.
2 capsules after the two largest meals of the day
Placebo
Placebo. 2 capsules after the two largest meals of the day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged \> 30
* Male or female
* Not taking anti-diabetic or lipid-lowering medication OR on a stable drug regimen for at least 3 months without any planned dosage change by the participants attending physician
* Have fasting blood glucose at or between 8-15 mmol/L
* Not taking any medications or natural health products that may affect serum parameters tested
* Having already been educated in exercise and dietary changes known to improve glucose control
Exclusion Criteria
* Patients taking insulin
* Pregnant or planned pregnancy
* Breastfeeding
* Known allergy to ingredients in Cinnamonforce
* Patients with underlying heart, liver, kidney, endocrine or neurologic disease
* Patients on an unstable hypoglycemic or lipid-lowering drug regime or patients on a drug regimen for less than 3 months, and patients taking medication that may affect serum parameters tested
30 Years
75 Years
ALL
No
Sponsors
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The Canadian College of Naturopathic Medicine
OTHER
University Health Network, Toronto
OTHER
Principal Investigators
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Rowena Ridout, MD
Role: PRINCIPAL_INVESTIGATOR
UHN
Jean-Jacques Dugoua, ND PhD(cand)
Role: STUDY_DIRECTOR
University of Toronto
Gideon Koren, MD
Role: STUDY_DIRECTOR
University Toronto
Tom Einarson, PhD
Role: STUDY_DIRECTOR
University of Toronto
Locations
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Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada
UHN - Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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dug2006-1
Identifier Type: -
Identifier Source: org_study_id