Trial Outcomes & Findings for Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS) (NCT NCT01483118)
NCT ID: NCT01483118
Last Updated: 2017-10-03
Results Overview
Ovulatory cycles will be confirmed by serum progesterone levels.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
45 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2017-10-03
Participant Flow
Advertizing in newspaper beginning in August 2011
Participant milestones
| Measure |
Cinnamon Extract Arm
Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
|
Placebo Arm
Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
Completed 3 Months
|
15
|
11
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
Cinnamon Extract Arm
Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
|
Placebo Arm
Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
16
|
Baseline Characteristics
Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Baseline characteristics by cohort
| Measure |
Cinnamon Extract Arm
n=23 Participants
Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
|
Placebo Arm
n=22 Participants
Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.95 years
n=5 Participants
|
27.86 years
n=7 Participants
|
27.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsOvulatory cycles will be confirmed by serum progesterone levels.
Outcome measures
| Measure |
Cinnamon Extract Arm
n=11 Participants
Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23
|
Placebo Arm
n=6 Participants
Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13
|
|---|---|---|
|
Number of Menses During the Six Month Study Period.
Baseline
|
.42 Number of menstrual cycles per month
Interval 0.33 to 0.63
|
.42 Number of menstrual cycles per month
Interval 0.29 to 0.68
|
|
Number of Menses During the Six Month Study Period.
Study Period
|
.75 Number of menstrual cycles per month
Interval 0.5 to 0.83
|
.25 Number of menstrual cycles per month
Interval 0.0 to 0.54
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of \>2 is considered healthy for adults with scores \>5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes).
Outcome measures
| Measure |
Cinnamon Extract Arm
n=11 Participants
Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23
|
Placebo Arm
n=6 Participants
Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13
|
|---|---|---|
|
Change in Insulin Resistance
Homeostasis Model of Insulin Resistance - Baseline
|
2.3 Insulin sensitivity indices
Interval 1.4 to 2.8
|
1.8 Insulin sensitivity indices
Interval 0.71 to 3.3
|
|
Change in Insulin Resistance
Homeostasis Model of Insulin Resistance - 6 months
|
2.5 Insulin sensitivity indices
Interval 0.97 to 3.3
|
1.2 Insulin sensitivity indices
Interval 0.78 to 2.6
|
|
Change in Insulin Resistance
Quant. Insulin Sensitivity Check Index - Baseline
|
.34 Insulin sensitivity indices
Interval 0.33 to 0.36
|
.35 Insulin sensitivity indices
Interval 0.32 to 0.41
|
|
Change in Insulin Resistance
Quant. Insulin Sensitivity Check Index - 6 months
|
.33 Insulin sensitivity indices
Interval 0.32 to 0.39
|
.37 Insulin sensitivity indices
Interval 0.33 to 0.4
|
SECONDARY outcome
Timeframe: Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestionChange in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion.
Outcome measures
| Measure |
Cinnamon Extract Arm
n=11 Participants
Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.75 Change during study +/- cycles/month +0.23
|
Placebo Arm
n=6 Participants
Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal.
Baseline (no. of cycles/month) 0.42 Study period (no. of cycles/month) 0.25 Change during study +/- cycles/month -0.13
|
|---|---|---|
|
Change in Glucose Response
Glucose Response (Area under curve) - Baseline
|
16,485 mg/dL*min
|
13,298 mg/dL*min
|
|
Change in Glucose Response
Glucose Response (Area under curve) - 6 months
|
16,515 mg/dL*min
|
15,420 mg/dL*min
|
Adverse Events
Cinnamon Extract Arm
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cinnamon Extract Arm
n=23 participants at risk
PCOS patients receiving extract of cinnamon
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
|
Placebo Arm
n=22 participants at risk
PCOS patients receiving placebo capsules
Placebo: Placebo capsules containing ground cereal.
|
|---|---|---|
|
General disorders
Right leg swelling with pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
Other adverse events
| Measure |
Cinnamon Extract Arm
n=23 participants at risk
PCOS patients receiving extract of cinnamon
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
|
Placebo Arm
n=22 participants at risk
PCOS patients receiving placebo capsules
Placebo: Placebo capsules containing ground cereal.
|
|---|---|---|
|
Gastrointestinal disorders
Acid reflux
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Anxiety
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Back pain
|
13.0%
3/23 • Number of events 11
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Bodyache
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Breast tenderness
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Bruise on thigh
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Bunion
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Cold
|
13.0%
3/23 • Number of events 6
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Congestion
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 4
|
0.00%
0/22
|
|
Reproductive system and breast disorders
Menstrual cramps
|
26.1%
6/23 • Number of events 7
|
13.6%
3/22 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
13.0%
3/23 • Number of events 5
|
0.00%
0/22
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
Reproductive system and breast disorders
Enlarged breast
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Feet swelling
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Hands/palms swelling
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Hangover
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Headache
|
43.5%
10/23 • Number of events 34
|
40.9%
9/22 • Number of events 10
|
|
Gastrointestinal disorders
Heartburn
|
13.0%
3/23 • Number of events 19
|
0.00%
0/22
|
|
General disorders
Heightened sense of smell
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Insomnia
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
4.3%
1/23 • Number of events 2
|
0.00%
0/22
|
|
General disorders
Lightheadedness
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Migraine
|
8.7%
2/23 • Number of events 4
|
4.5%
1/22 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Nasal congestion
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Nausea
|
13.0%
3/23 • Number of events 9
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Overdose
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Pain
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
Eye disorders
Pink eye
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Itchy rash
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Sleep problem
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Sleepiness
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Sore throat
|
4.3%
1/23 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Stomachache
|
13.0%
3/23 • Number of events 5
|
0.00%
0/22
|
|
General disorders
Stomach cramps
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Swelling of face (cheeks)
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
Eye disorders
Stye in eye
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Swelling of feet and hands
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Swelling of lips
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Swelling/puffiness of eye area
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Throat/nasal congestion
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
|
General disorders
Tiredness
|
4.3%
1/23 • Number of events 7
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Toothache
|
4.3%
1/23 • Number of events 1
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Trouble falling asleep
|
0.00%
0/23
|
4.5%
1/22 • Number of events 2
|
|
Gastrointestinal disorders
Upset stomach
|
8.7%
2/23 • Number of events 3
|
0.00%
0/22
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
Additional Information
Roger A. Lobo M.D.
Columbia University, Department of OBGYN
Phone: 212-3056337
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place