Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics

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.

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