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

November 19, 2007 updated by: University Health Network, Toronto

The Anti-Diabetic and Cholesterol-Lowering Effects of Cinnamon and Cassia Bark (Cinnamomum Verum and C. Aromaticum) (Cinnamonforce™) - Randomized Placebo-Controlled Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, m2k 1E2
        • Recruiting
        • Canadian College of Naturopathic Medicine
        • Principal Investigator:
          • Jean-Jacques Dugoua, NDPhD (cand)
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • UHN - Toronto Western Hospital
        • Principal Investigator:
          • Rowena Ridout, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo. 2 capsules after the two largest meals of the day
Active Comparator: 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.
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

Other Names:
  • Cinnamonforce by New Chapter

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

The Canadian College of Naturopathic Medicine

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

May 28, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimate)

May 30, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2007

Last Update Submitted That Met QC Criteria

November 19, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dug2006-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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