NCT00479973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

May 28, 2007

Last Update Submit

November 19, 2007

Conditions

Type 2 DiabetesHypercholesterolemia

Keywords

diabetesnon-insulin dependant diabetestype 2 diabetescinnamonnatural health producthypercholesterolemiadyslipidemiaelevated cholesterol

Outcome Measures

Primary Outcomes (1)

  • The primary objective measures will consist of fasting blood glucose, insulin and HA1C.

    3 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

Cinnamonforce

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

CinnamonforceDIETARY_SUPPLEMENT

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

Also known as: Cinnamonforce by New Chapter
Cinnamonforce
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Canadian College of Naturopathic Medicine

Toronto, Ontario, m2k 1E2, Canada

RECRUITING

UHN - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypercholesterolemiaDiabetes MellitusDyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasLipid Metabolism Disorders

Study Officials

  • Rowena Ridout, MD

    UHN

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Central Study Contacts

Jean-Jacques Dugoua, ND PhD(cand)

CONTACT

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

Rowena Ridout, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2007

First Posted

May 30, 2007

Study Start

September 1, 2007

Study Completion

May 1, 2008

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

CA(2)