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Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.

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ClinicalTrials.gov Identifier: NCT01302743
Recruitment Status : Terminated (lack of recruitment)
First Posted : February 24, 2011
Results First Posted : March 28, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes
Interventions Drug: Group 1: Metformin
Dietary Supplement: Group 2: Cinnamon Bark
Dietary Supplement: Group 3: Cinnulin PF
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin Cinnamon Bark Cinnulin PF
Hide Arm/Group Description

oral extended-release Metformin 1000 mg once a day for 90 days

Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark 1000 mg once a day for 90 days

Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF 500 mg once a day for 90 days

Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Period Title: Overall Study
Started 7 8 10
Completed 6 7 8
Not Completed 1 1 2
Arm/Group Title Metformin Cinnamon Bark Cinnulin PF Total
Hide Arm/Group Description

oral extended-release Metformin 1000 mg once a day for 90 days

Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark 1000 mg once a day for 90 days

Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF 500 mg once a day for 90 days

Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Total of all reporting groups
Overall Number of Baseline Participants 7 8 10 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 10 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  71.4%
4
  50.0%
8
  80.0%
17
  68.0%
>=65 years
2
  28.6%
4
  50.0%
2
  20.0%
8
  32.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 8 participants 10 participants 25 participants
Female
3
  42.9%
4
  50.0%
2
  20.0%
9
  36.0%
Male
4
  57.1%
4
  50.0%
8
  80.0%
16
  64.0%
1.Primary Outcome
Title Decrease in HbA1c
Hide Description Subjects will have baseline blood levels to measure HbA1c. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
no data was analyzed as study was stopped early due to low recruitment
Arm/Group Title Metformin Cinnamon Bark Cinnulin PF
Hide Arm/Group Description:

oral extended-release Metformin 1000 mg once a day for 90 days

Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark 1000 mg once a day for 90 days

Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF 500 mg once a day for 90 days

Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Decrease in LDL Cholesterol
Hide Description Subjects will have baseline blood levels to measure LDL Cholesterol. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
no data was analyzed as study was stopped early due to low recruitment
Arm/Group Title Metformin Cinnamon Bark Cinnulin PF
Hide Arm/Group Description:

oral extended-release Metformin 1000 mg once a day for 90 days

Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark 1000 mg once a day for 90 days

Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF 500 mg once a day for 90 days

Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Cinnamon Bark Cinnulin PF
Hide Arm/Group Description

oral extended-release Metformin 1000 mg once a day for 90 days

Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark 1000 mg once a day for 90 days

Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF 500 mg once a day for 90 days

Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

All-Cause Mortality
Metformin Cinnamon Bark Cinnulin PF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/8 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Metformin Cinnamon Bark Cinnulin PF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/8 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Cinnamon Bark Cinnulin PF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/8 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jill M. Clark, MBA/HCM
Organization: Mike O'Callaghan Federal Medical Center
Phone: 702-653-3298
EMail: jill.clark.3.ctr@us.af.mil
Layout table for additonal information
Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT01302743     History of Changes
Other Study ID Numbers: FWH20110004H
First Submitted: February 17, 2011
First Posted: February 24, 2011
Results First Submitted: December 15, 2016
Results First Posted: March 28, 2017
Last Update Posted: June 26, 2017