Trial record 10 of 43 for:    Open Studies | "Hypoglycemic Agents"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Canadian College of Naturopathic Medicine
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00479973
First received: May 28, 2007
Last updated: November 19, 2007
Last verified: November 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Arms Assigned Interventions
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 Name: Cinnamonforce by New Chapter
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo. 2 capsules after the two largest meals of the day

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
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00479973     History of Changes
Other Study ID Numbers: dug2006-1
Study First Received: May 28, 2007
Last Updated: November 19, 2007
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
diabetes
non-insulin dependant diabetes
type 2 diabetes
cinnamon
natural health product
hypercholesterolemia
dyslipidemia
elevated cholesterol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014