Trial Outcomes & Findings for Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM. (NCT NCT01302743)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

90 days

Results posted on

2017-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Metformin 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 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 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 Study STARTED	7	8	10
Overall Study COMPLETED	6	7	8
Overall Study NOT COMPLETED	1	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin n=7 Participants 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 n=8 Participants 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 n=10 Participants 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 n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	17 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	16 Participants n=4 Participants

PRIMARY outcome

Timeframe: 90 days

Population: no data was analyzed as study was stopped early due to low recruitment

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 90 days

Population: no data was analyzed as study was stopped early due to low recruitment

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.

Outcome measures

Outcome measures
Measure	Metformin 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 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 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.
Decrease in LDL Cholesterol	0	0	0

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cinnamon Bark

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cinnulin PF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jill M. Clark, MBA/HCM

Mike O'Callaghan Federal Medical Center

Phone: 702-653-3298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place