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

March 5, 2024 updated by: Mike O'Callaghan Military Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Travis Air Force Base, California, United States, 94535
        • Travis Air Force Base
    • Florida
      • Eglin Air Force Base, Florida, United States, 32922
        • Eglin Air Foce Base
    • Nebraska
      • Offutt Air Force Base, Nebraska, United States, 68113
        • Offutt Air Force Base
    • Texas
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Ambulatory Surgical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 1 year 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 12 months plus standard of care aggressive lifestyle therapy
Other Names:
  • Cinnulin PF
Placebo Comparator: Placebo
Will take (by mouth) 2 placebo capsules (gelatin capsule filled with wheat bran) once a day for 1 year plus 1 year 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 12 months plus standard of care aggressive lifestyle therapy
Other Names:
  • Cinnulin PF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Water-soluble Cinnamon
Time Frame: 1 year
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?
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

  • Principal Investigator: Paul Crawford, M.D., Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2013

Primary Completion (Actual)

April 26, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimated)

February 23, 2011

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20110035H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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