NCT01301521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 11, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

April 3, 2024

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

5.9 years

First QC Date

February 18, 2011

Results QC Date

March 5, 2024

Last Update Submit

March 5, 2024

Conditions

DiabetesPre-Diabetes

Keywords

Pre-Diabetescinnamon

Outcome Measures

Primary Outcomes (1)

  • 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?

    1 year

Study Arms (2)

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.

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.

Drug: water-soluble cinnamon extract (Cinnulin PF)

Interventions

water-soluble cinnamon extract (Cinnulin PF)DRUG

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

Also known as: Cinnulin PF
Cinnulin PFPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Travis Air Force Base

Travis Air Force Base, California, 94535, United States

Location

Eglin Air Foce Base

Eglin Air Force Base, Florida, 32922, United States

Location

Offutt Air Force Base

Offutt Air Force Base, Nebraska, 68113, United States

Location

Wilford Hall Ambulatory Surgical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (1)

  • 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.

    PMID: 26732017DERIVED

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Interventions

cinnulin PF

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Results Point of Contact

Title
Amanda Crawford
Organization
MOMH
amanda.j.crawford.ctr@health.mil
702-653-3583

Study Officials

  • Paul Crawford, M.D.

    Mike O'Callaghan Federal Hospital/Nellis Air Force Base

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

June 11, 2013

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

April 3, 2024

Results First Posted

April 3, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)