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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Type 2 Diabetes, Hypercholesterolemia

Intervention / Treatment
-----------------
* Dietary Supplement: Cinnamonforce
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cinnamonforce<br>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<br>* 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<br>* Other names: Cinnamonforce by New Chapter;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo. 2 capsules after the two largest meals of the day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective measures will consist of fasting blood glucose, insulin and HA1C. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, non-insulin dependant diabetes, type 2 diabetes, cinnamon, natural health product, hypercholesterolemia, dyslipidemia, elevated cholesterol