Trial Outcomes & Findings for Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics (NCT NCT01301521)
NCT ID: NCT01301521
Last Updated: 2024-04-03
Results Overview
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?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
229 participants
Primary outcome timeframe
1 year
Results posted on
2024-04-03
Participant Flow
Participant milestones
| Measure |
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.
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
|
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
113
|
|
Overall Study
COMPLETED
|
47
|
43
|
|
Overall Study
NOT COMPLETED
|
69
|
70
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics
Baseline characteristics by cohort
| Measure |
Cinnulin PF
n=116 Participants
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.
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
|
Placebo
n=113 Participants
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.
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
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
116 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
229 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearDoes 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?
Outcome measures
| Measure |
Cinnulin PF
n=47 Participants
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.
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
|
Placebo
n=43 Participants
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.
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
|
|---|---|---|
|
Water-soluble Cinnamon
diabetes conversion: yes
|
15 Participants
|
11 Participants
|
|
Water-soluble Cinnamon
diabetes conversion: no
|
32 Participants
|
32 Participants
|
Adverse Events
Cinnulin PF
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cinnulin PF
n=116 participants at risk
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.
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
|
Placebo
n=113 participants at risk
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.
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
|
|---|---|---|
|
General disorders
Unrelated to Medicine
|
23.3%
27/116 • Number of events 27 • 1 year
|
24.8%
28/113 • Number of events 28 • 1 year
|
|
General disorders
Medication Reaction
|
12.1%
14/116 • Number of events 14 • 1 year
|
1.8%
2/113 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place