Recruiting
Phase 2

Cinnamon & Cassia

Sponsor:

University Health Network, Toronto

Code:

NCT00479973

Conditions

Type 2 Diabetes

Hypercholesterolemia

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Cinnamonforce

Placebo

Study Details

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.

Conditions

Type 2 Diabetes

Hypercholesterolemia

Study ID

NCT00479973

Start date

Sep, 2007

Status verified date

Nov, 2007

Completion date

May, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

placebo comparator: Placebo

Interventions

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

Placebo

Placebo. 2 capsules after the two largest meals of the day

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jean-Jacques Dugoua, ND PhD(cand)

416-666-4307jeanjacques.dugoua@uhn.on.ca

Rowena Ridout, MD

416-603-6454rowena.ridout@uhn.on.ca

Locations

Canadian College of Naturopathic Medicine

Recruiting

Toronto, Ontario, Canada, m2k 1E2

Principal Investigator:

Jean-Jacques Dugoua, NDPhD (cand)

UHN - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Principal Investigator:

Rowena Ridout, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 20, 2007

Last verified

Nov, 2007

Keywords

  • diabetes
  • non-insulin dependant diabetes
  • type 2 diabetes
  • cinnamon
  • natural health product
  • hypercholesterolemia
  • dyslipidemia
  • elevated cholesterol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2007-11-20.