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.
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.
|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.|
- 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?
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301521
|Contact: Jill M Clark, MBA/HCM, CCRP, CCRCfirstname.lastname@example.org|
|United States, California|
|Travis Air Force Base||Recruiting|
|Travis AFB, California, United States, 94535|
|Contact: Michelle Woo 707-423-7704 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Mark True, M.D.|
|Principal Investigator:||Paul Crawford, M.D.||Mike O'Callaghan Federal Hospital/Nellis Air Force Base|