Cinnamon Trial—Assessment of the effeCt of lIfestyle iNtervention Plus Water-soluble ciNnAMon Extract On loweriNg Blood Glucose in Pre-diabetics: A Randomized, Double-blind, Multicenter, Placebo Controlled TRIAL.

This study is currently recruiting participants.
Verified November 2013 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01301521
First received: February 18, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess whether water-soluble cinnamon extract plus aggressive lifestyle intervention is effective in lowering blood glucose in pre-diabetic patients when compared to aggressive lifestyle therapy plus placebo.


Condition Intervention
Diabetes
Pre-Diabetes
Drug: water-soluble cinnamon extract (Cinnulin PF)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Cinnamon Trial—Assessment of the effeCt of lIfestyle iNtervention Plus Water-soluble ciNnAMon Extract On loweriNg Blood Glucose in Pre-diabetics: A Randomized, Double-blind, Multicenter, Placebo Controlled TRIAL.

Resource links provided by NLM:


Further study details as provided by Mike O'Callaghan Federal Hospital:

Primary Outcome Measures:
  • water-soluble cinnamon [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Does water-soluble cinnamon extract delay the onset of diabetes or extend the time to diagnosis of diabetes in pre-diabetic patients who are already undergoing aggressive lifestyle therapy?


Estimated Enrollment: 557
Study Start Date: November 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinnulin PF
Will take (by mouth) 2 gelatin capsules that contains 1 gram (2-500 mg capsules) water-soluble cinnamon extract (Cinnulin PF) once a day for 1 year plus 2 years of follow-up plus standard of care aggressive lifestyle therapy.
Drug: water-soluble cinnamon extract (Cinnulin PF)
Will take (by mouth) 1 gelatin capsule that contains 1 gram water-soluble cinnamon extract (Cinnulin PF) once a day for 36 months plus standard of care aggressive lifestyle therapy
Placebo Comparator: Placebo
Will take (by mouth) 2 placebo capsules (gelatin capsule filled with wheat bran) once a day for 1 year plus 2 years of follow-up plus standard of care aggressive lifestyle therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Patients will be MOFMC, WHASC, DGMC, Eglin, and Offutt DoD beneficiaries, ages 18-65 years.
  • Diagnosis of pre-diabetes (defined as a fasting plasma glucose (FPG) 100-125mg/dl, Hemoglobin A1c 5.7-6.4%, or a 2-hour oral glucose tolerance test (OGTT) 140-199).

Exclusion:

  • Patients who are less than 18 yrs of age or greater than 65 years of age.
  • Patients who are known to have or develop during the study any of the following upon review of their medical record:

    • Diabetes Mellitus (defined as fasting plasma glucose (FPG) ≥126mg/dl, hemoglobin A1C ≥6.5%, or a 2-hour oral glucose tolerance test (OGTT) ≥200mg/dl)
    • Stage 3 kidney disease or worse
    • Renal insufficiency defined as a glomerular filtration rate (gfr) of less than 60ml
    • Celiac disease
    • Insulinoma
    • Cushing's disease
    • Hyperthyroidism
    • Acromegaly
    • Pheochromocytoma
    • Addison's disease
    • Galactosemia
    • Glycogen storage disease
    • Hereditary fructose intolerance
  • Patients taking any of the following:

    • Cinnamon as a dietary supplement
    • Daily oral steroids
    • Warfarin
    • Hypoglycemic medication
    • Weight loss medication
    • Digoxin, lithium, phenytoin, & theophylline (due to their narrow therapeutic indices)
  • Patients who are pregnant or breast feeding
  • Patients with a known allergy to cinnamon
  • Patients with a known allergy to wheat
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301521

Contacts
Contact: Jill M Clark, MBA/HCM, CCRP, CCRC 7026533298 jill.clark.3.ctr@us.af.mil

Locations
United States, California
Travis Air Force Base Recruiting
Travis AFB, California, United States, 94535
Contact: Michelle Woo    707-423-7704    michelle.woo.ctr@us.af.mil   
Principal Investigator: Katherine Mansalis, M.D.         
United States, Florida
Eglin Air Foce Base Recruiting
Eglin AFB, Florida, United States, 32922
Contact: Carmen Jones    850-875-9501    carmen.jones.1.ctr@us.af.mil   
Principal Investigator: Philip Dooley, MD         
United States, Nebraska
Offutt Air Force Base Recruiting
Offutt AFB, Nebraska, United States, 68113
Contact: Eunite Treat    402-232-2528    eunite.treat.ctr@us.af.mil   
Principal Investigator: John Hallgren, M.D         
United States, Texas
Wilford Hall Ambulatory Surgical Center Recruiting
Lackland AFB, Texas, United States, 78236
Contact: Rebecca Gonzalez    210-292-4701    rebecca.gonzales.3.ctr@us.af.mil   
Principal Investigator: Mark True, M.D.         
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
Principal Investigator: Paul Crawford, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base
  More Information

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01301521     History of Changes
Other Study ID Numbers: FWH20110035H
Study First Received: February 18, 2011
Last Updated: November 21, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Mike O'Callaghan Federal Hospital:
Pre-Diabetes
cinnamon

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on April 23, 2014