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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014