Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University Health Network, Toronto The Canadian College of Naturopathic Medicine |
---|---|
Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00479973 |
Introduction: According to the World Health Organization (WHO), approximately 150 million people worldwide have type 2 diabetes. Common and cassia cinnamon have been reported to have anti-diabetic and lipid-lowering effects. 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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Hypercholesterolemia |
Dietary Supplement: Cinnamonforce Dietary Supplement: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Anti-Diabetic and Cholesterol-Lowering Effects of Cinnamon and Cassia Bark (Cinnamomum Verum and C. Aromaticum) (Cinnamonforce™) - Randomized Placebo-Controlled Clinical Trial |
Estimated Enrollment: | 70 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
---|---|
Cinnamonforce: Active Comparator
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.
|
Dietary Supplement: 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 Comparator |
Dietary Supplement: Placebo
Placebo. 2 capsules after the two largest meals of the day
|
A randomized placebo-controlled clinical trial will be conducted to evaluate the impact of Cinnamonforce™ on different serum markers related to diabetes and lipid management. 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. Based on inclusion and exclusion criteria outlined in 13A, seventy (70) participants will be randomized using a computer-derived random number generator to the treatment group where they will receive Cinnamonforce™ or to the control group where they will receive a placebo. The manufacturer of Cinnamonforce™, New Chapter, will generate the treatment allocations and retain these in sealed opaque envelopes until the end of the trial. Patients, investigators, and statisticians will be blinded until the end of the trial. Participants will be administered 140 mg of Cinnamonforce™ twice daily or placebo of identical size, shape, colour and odour. Patients will be instructed to take two capsules (140 mg) at the end of each of the two largest meals of the day for 3 months. Compliance will be assessed by pill count.Participants will be asked to come in for assessment at predefined time points including: baseline, 2 weeks, 4 weeks, 8 weeks and end point (13 weeks). At each time point, objective and subjective measurements will be obtained.
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.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean-Jacques Dugoua, ND PhD(cand) | 416-666-4307 | jeanjacques.dugoua@uhn.on.ca |
Contact: Rowena Ridout, MD | 416-603-6454 | rowena.ridout@uhn.on.ca |
Canada, Ontario | |
UHN - Toronto Western Hospital | Recruiting |
Toronto, Ontario, Canada, M5T 2S8 | |
Principal Investigator: Rowena Ridout, MD | |
Canadian College of Naturopathic Medicine | Recruiting |
Toronto, Ontario, Canada, m2k 1E2 | |
Principal Investigator: Jean-Jacques Dugoua, NDPhD (cand) |
Principal Investigator: | Rowena Ridout, MD | UHN |
Study Director: | Jean-Jacques Dugoua, ND PhD(cand) | University of Toronto |
Study Director: | Gideon Koren, MD | University Toronto |
Study Director: | Tom Einarson, PhD | University of Toronto |
Study ID Numbers: | dug2006-1 |
Study First Received: | May 28, 2007 |
Last Updated: | November 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00479973 History of Changes |
Health Authority: | Canada: Health Canada |
diabetes non-insulin dependant diabetes type 2 diabetes cinnamon |
natural health product hypercholesterolemia dyslipidemia elevated cholesterol |
Hypoglycemic Agents Hyperlipidemias Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Hypoglycemic Agents Hyperlipidemias Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Pharmacologic Actions Dyslipidemias Lipid Metabolism Disorders |