Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479973
Status:
UNKNOWN
Last Update Posted:
2007-11-20
First Post:
2007-05-28
Brief Title:
The Anti-Diabetic and Cholesterol-Lowering Effects of Cinnamon and Cassia Bark
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 countParticipants 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 cholesteroltriglycerides HDL and LDL Other secondary objective measures will consist of blood pressure weight body mass index BMI waisthip 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 questionnairesie Diabetes-39 SF-36
The primary objective measures will consist of fasting blood glucose insulin and HA1C Secondary biochemical measures will include a lipid panel total cholesteroltriglycerides HDL and LDL Other secondary objective measures will consist of blood pressure weight body mass index BMI waisthip 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 questionnairesie Diabetes-39 SF-36
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None