The Anti-Diabetic and Cholesterol-Lowering Effects of C...

The Anti-Diabetic and Cholesterol-Lowering Effects of Cinnamon and Cassia Bark

The Anti-Diabetic and Cholesterol-Lowering Effects of Cinnamon and Cassia Bark

This study is currently recruiting participants.
Verified by University Health Network, Toronto, November 2007

Sponsors and Collaborators: University Health Network, Toronto
The Canadian College of Naturopathic Medicine

Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00479973

Purpose
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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes Dietary Supplements

Drug Information available for: Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
The primary objective measures will consist of fasting blood glucose, insulin and HA1C. [ Time Frame: 3 months ]

Secondary Outcome Measures:
Total-C, TG, HDL, LDL, BP, weight, BMI, waist/hip ratio, self-monitoring blood glucose, HOMA-IR, AST, ALT, total protein, albumin, alk phos, total/direct bilirubin, creatinine, BUN, PT, PTT, fibrinogen, adverse effects, Diabetes-39, SF-36 [ Time Frame: 3 months ]

Estimated Enrollment: 70
Study Start Date: September 2007
Estimated Study Completion Date: May 2008

Detailed Description:
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.

Eligibility
Ages Eligible for Study: 30 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Diagnosed with type 2 diabetes
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:

Type 1 diabetics
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

Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier: NCT00479973

Contacts

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

Locations

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)

Sponsors and Collaborators

University Health Network, Toronto

The Canadian College of Naturopathic Medicine