DiabetesCinnamonNCT01301521
Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics
A study testing water-soluble cinnamon extract (Cinnulin PF) in people with Diabetes and Pre-Diabetes, run by Mike O'Callaghan Military Hospital at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Pre-Diabetes
- What is being tested?
- water-soluble cinnamon extract (Cinnulin PF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 229 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jun 2013to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Eglin Air Foce Base
Eglin Air Force Base, Florida, 32922
Wilford Hall Ambulatory Surgical Center
Lackland Air Force Base, Texas, 78236
Offutt Air Force Base
Offutt Air Force Base, Nebraska, 68113
Travis Air Force Base
Travis Air Force Base, California, 94535
About this study
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.
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.
Read the 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.
- Conditions
- Diabetes, Pre-Diabetes
- Being tested
- water-soluble cinnamon extract (Cinnulin PF)
- Keywords
- Pre-Diabetes, cinnamon
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water-soluble cinnamon extract (Cinnulin PF)Drug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Cinnulin PF | Experimental | 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. Receives: Drug: water-soluble cinnamon extract (Cinnulin PF) |
| Placebo | Placebo comparator | 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. Receives: Drug: water-soluble cinnamon extract (Cinnulin PF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water-soluble Cinnamon
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?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study start11 Jun 2013
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul Crawford, M.D., Principal investigator, Mike O'Callaghan Federal Hospital/Nellis Air Force Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301521
- Sponsor's protocol ID
- FWH20110035H
- Acronym
- Cinnamon
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2011
- Last updated
- 3 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26732017
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01301521
- Acronym / sponsor ID
- Cinnamon / FWH20110035H
- Conditions
- Diabetes, Pre-Diabetes
- Keywords
- Pre-Diabetes, cinnamon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- 11 Jun 2013 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Posted 3 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnulin PF | Experimental | Drug: water-soluble cinnamon extract (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. |
| Placebo | Placebo comparator | Drug: water-soluble cinnamon extract (Cinnulin PF)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water-soluble cinnamon extract (Cinnulin PF)Also: Cinnulin PFWill 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 | Drug | Cinnulin PF, Placebo |
Primary outcome
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?
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26732017Crawford 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Crawford, M.D. principal investigator
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water-soluble cinnamon extract (Cinnulin PF) in people with Diabetes and Pre-Diabetes, run by Mike O'Callaghan Military Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Water-soluble Cinnamon (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01301521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.