Clinical trial NCT01301521: Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Pre-Diabetes
Keywords: Pre-Diabetes
cinnamon
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2011-02-23
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: We are studying whether water-soluble cinnamon extract (Cinnulin PF) plus standard of care aggressive lifestyle therapy is effective in lowering blood glucose when compared to placebo plus standard of care aggressive life style therapy. Eligible subjects will be recruited from any form and any stage of "standard" lifestyle intervention for pre-diabetes at an individual base. "Standard" lifestyle intervention for pre-diabetes could include Group Lifestyle Balance (GLB), nutrition classes, Better Body/Better Life, or anything an investigator certifies as standard practice at that base. Subjects will take either 1 gram (2-500 milligram (mg) capsules) of water-soluble cinnamon extract (Cinnulin PF) or 2 placebo pills (gelatin capsule filled with wheat bran) once a day for 1 year plus 1 additional year of follow-up. This is a randomized, double-blind, multicenter, placebo-controlled study which will enroll subjects at the Mike O'Callaghan Federal Medical Center (MOFMC), Wilford Hall Ambulatory Surgical Center (WHASC), David Grant Medical Center (DGMC), Eglin Air Force Base (Eglin), and Offutt Air Force Base (Offutt). All subjects will be MOFMC, WHASC, DGMC, Eglin, and Offutt DoD beneficiaries. Informed Consent and HIPAA Authorization will be obtained. After randomization, subjects will receive either 1 gram (2-500 mg capsules) of water-soluble cinnamon extract or placebo from the pharmacy--thus investigators and subjects will be blinded as to if they are taking Cinnulin PF or 2 placebo pills. Subjects will be permitted to have usual medical care for other co-morbid, preventive, and acute conditions. Analysis will be performed using intention-to-treat principles for missing data (the carry-forward method to impute missing data will be used). Subjects will bring in any remaining water-soluble cinnamon extract or placebo to determine adherence rates to the study protocol.

Eligibility criteria: THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

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) greater than 126mg/dl, hemoglobin A1C greater than 6.5%, or a 2-hour oral glucose tolerance test (OGTT) greater than 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

Primary outcomes:
measure: Water-soluble Cinnamon
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: Travis Air Force Base
state: California
city: Eglin Air Force Base
country: United States
facility: Eglin Air Foce Base
state: Florida
city: Offutt Air Force Base
country: United States
facility: Offutt Air Force Base
state: Nebraska
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
Study officials:
affiliation: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
name: Paul Crawford, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crawford P, Thai C, Obholz J, Schievenin J, True M, Shah SA, Hallgren J, Clark J, Sharon D. 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: study protocol for a randomized controlled trial. Trials. 2016 Jan 5;17:9. doi: 10.1186/s13063-015-1138-7.