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Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT01483118
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : August 2, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Integrity Nutraceuticals International
Information provided by (Responsible Party):
Rogerio A. Lobo, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Polycystic Ovary Syndrome
Interventions Drug: Cinnamon Extract
Dietary Supplement: Placebo
Enrollment 45
Recruitment Details Advertizing in newspaper beginning in August 2011
Pre-assignment Details  
Arm/Group Title Cinnamon Extract Arm Placebo Arm
Hide Arm/Group Description

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 capsules containing ground cereal.

Placebo: Placebo capsules containing ground cereal.
Period Title: Overall Study
Started 23 22
Completed 3 Months 15 11
Completed [1] 11 6
Not Completed 12 16
Reason Not Completed
Lost to Follow-up             12             16
[1]
(entire 6 months)
Arm/Group Title Cinnamon Extract Arm Placebo Arm Total
Hide Arm/Group Description

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 capsules containing ground cereal.

Placebo: Placebo capsules containing ground cereal.

 Total of all reporting groups
Overall Number of Baseline Participants 23 22 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 45 participants
26.95
(18 to 34)
27.86
(18 to 38)
27.5
(18 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
Female
23
 100.0%
22
 100.0%
45
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
Hispanic or Latino
8
  34.8%
8
  36.4%
16
  35.6%
Not Hispanic or Latino
14
  60.9%
13
  59.1%
27
  60.0%
Unknown or Not Reported
1
   4.3%
1
   4.5%
2
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 22 participants 45 participants
23 22 45
1.Primary Outcome
Title Number of Menses During the Six Month Study Period.
Hide Description Ovulatory cycles will be confirmed by serum progesterone levels.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cinnamon Extract Arm Placebo Arm
Hide Arm/Group Description:

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 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
Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Number of menstrual cycles per month
Baseline
.42
(.33 to .63)
.42
(.29 to .68)
Study Period
.75
(.5 to .83)
.25
(0 to .54)
2.Secondary Outcome
Title Change in Insulin Resistance
Hide Description The 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).
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cinnamon Extract Arm Placebo Arm
Hide Arm/Group Description:

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 capsules containing ground cereal.

Placebo: Placebo capsules containing ground cereal.
Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: Insulin sensitivity indices
Homeostasis Model of Insulin Resistance - Baseline
2.3
(1.4 to 2.8)
1.8
(.71 to 3.3)
Homeostasis Model of Insulin Resistance - 6 months
2.5
(.97 to 3.3)
1.2
(.78 to 2.6)
Quant. Insulin Sensitivity Check Index - Baseline
.34
(.33 to .36)
.35
(.32 to .41)
Quant. Insulin Sensitivity Check Index - 6 months
.33
(.32 to .39)
.37
(.33 to .40)
3.Secondary Outcome
Title Change in Glucose Response
Hide Description Change 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.
Time Frame Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cinnamon Extract Arm Placebo Arm
Hide Arm/Group Description:

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 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
Overall Number of Participants Analyzed 11 6
Median (Inter-Quartile Range)
Unit of Measure: mg/dL*min
Glucose Response (Area under curve) - Baseline
16,485
(13,995 to 18,964)
13,298
(11,993 to 15,285)
Glucose Response (Area under curve) - 6 months
16,515
(15,068 to 20,190)
15,420
(14,468 to 17,798)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cinnamon Extract Arm Placebo Arm
Hide Arm/Group Description

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.

PCOS patients receiving placebo capsules

Placebo: Placebo capsules containing ground cereal.
All-Cause Mortality
Cinnamon Extract Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Cinnamon Extract Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/23 (4.35%)      0/22 (0.00%)    
General disorders     
Right leg swelling with pain * [1]  1/23 (4.35%)  1 0/22 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Hospitalized
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cinnamon Extract Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/23 (65.22%)      13/22 (59.09%)    
Eye disorders     
Pink eye * [1]  0/23 (0.00%)  0 1/22 (4.55%)  1
Stye in eye *  0/23 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders     
Acid reflux *  1/23 (4.35%)  1 0/22 (0.00%)  0
Constipation *  1/23 (4.35%)  4 0/22 (0.00%)  0
Diarrhea *  3/23 (13.04%)  5 0/22 (0.00%)  0
Gastroenteritis *  1/23 (4.35%)  1 0/22 (0.00%)  0
Heartburn *  3/23 (13.04%)  19 0/22 (0.00%)  0
Upset stomach *  2/23 (8.70%)  3 0/22 (0.00%)  0
Vomiting *  1/23 (4.35%)  1 0/22 (0.00%)  0
General disorders     
Anxiety *  1/23 (4.35%)  1 0/22 (0.00%)  0
Back pain *  3/23 (13.04%)  11 1/22 (4.55%)  1
Bodyache *  1/23 (4.35%)  1 0/22 (0.00%)  0
Breast tenderness *  0/23 (0.00%)  0 1/22 (4.55%)  1
Bruise on thigh *  1/23 (4.35%)  1 0/22 (0.00%)  0
Bunion *  0/23 (0.00%)  0 1/22 (4.55%)  1
Chest pain *  0/23 (0.00%)  0 1/22 (4.55%)  1
Cold *  3/23 (13.04%)  6 1/22 (4.55%)  1
Congestion *  1/23 (4.35%)  1 0/22 (0.00%)  0
Feet swelling *  1/23 (4.35%)  1 0/22 (0.00%)  0
Hands/palms swelling *  1/23 (4.35%)  1 0/22 (0.00%)  0
Hangover *  1/23 (4.35%)  1 0/22 (0.00%)  0
Headache *  10/23 (43.48%)  34 9/22 (40.91%)  10
Heightened sense of smell *  0/23 (0.00%)  0 1/22 (4.55%)  1
Insomnia *  1/23 (4.35%)  1 0/22 (0.00%)  0
Lightheadedness *  1/23 (4.35%)  1 0/22 (0.00%)  0
Migraine *  2/23 (8.70%)  4 1/22 (4.55%)  1
Nasal congestion *  1/23 (4.35%)  1 0/22 (0.00%)  0
Nausea *  3/23 (13.04%)  9 1/22 (4.55%)  1
Overdose * [2]  0/23 (0.00%)  0 1/22 (4.55%)  1
Pain * [3]  1/23 (4.35%)  1 0/22 (0.00%)  0
Itchy rash * [4]  1/23 (4.35%)  1 0/22 (0.00%)  0
Sleep problem *  0/23 (0.00%)  0 1/22 (4.55%)  1
Sleepiness *  0/23 (0.00%)  0 1/22 (4.55%)  1
Sore throat *  1/23 (4.35%)  1 1/22 (4.55%)  1
Stomachache *  3/23 (13.04%)  5 0/22 (0.00%)  0
Stomach cramps *  1/23 (4.35%)  1 0/22 (0.00%)  0
Swelling of face (cheeks) *  1/23 (4.35%)  1 0/22 (0.00%)  0
Swelling of feet and hands *  1/23 (4.35%)  1 0/22 (0.00%)  0
Swelling of lips *  1/23 (4.35%)  1 0/22 (0.00%)  0
Swelling/puffiness of eye area *  1/23 (4.35%)  1 0/22 (0.00%)  0
Throat/nasal congestion *  1/23 (4.35%)  1 0/22 (0.00%)  0
Tiredness *  1/23 (4.35%)  7 1/22 (4.55%)  1
Toothache *  1/23 (4.35%)  1 1/22 (4.55%)  1
Trouble falling asleep *  0/23 (0.00%)  0 1/22 (4.55%)  2
Musculoskeletal and connective tissue disorders     
Joint pain *  1/23 (4.35%)  2 0/22 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Miscarriage *  1/23 (4.35%)  1 0/22 (0.00%)  0
Pregnancy *  0/23 (0.00%)  0 1/22 (4.55%)  1
Reproductive system and breast disorders     
Menstrual cramps *  6/23 (26.09%)  7 3/22 (13.64%)  7
Enlarged breast *  1/23 (4.35%)  1 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia *  0/23 (0.00%)  0 1/22 (4.55%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Right eye affected
[2]
1 extra dose taken
[3]
Due to stomachache
[4]
Due to bed bugs
High percentage of patients lost to follow up
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: Roger A. Lobo M.D.
Organization: Columbia University, Department of OBGYN
Phone: 212-3056337
EMail: ral35@columbia.edu
Publications:
Layout table for additonal information
Responsible Party: Rogerio A. Lobo, Columbia University
ClinicalTrials.gov Identifier: NCT01483118    
Other Study ID Numbers: AAAI1377
First Submitted: November 29, 2011
First Posted: December 1, 2011
Results First Submitted: May 26, 2016
Results First Posted: August 2, 2017
Last Update Posted: October 3, 2017