Trial · NCT01483118
Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
NCT01483118, Phase 3, Completed, Rogerio A. Lobo; results first posted 2017-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS). Trials, record NCT01483118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01483118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
- NCT number
- NCT01483118
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 45 participants, actual
- Lead sponsor
- Rogerio A. Lobo
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Cinnamon Extract, Placebo
- First posted
- 2011-12-01
- Last updated
- 2017-10-03
- Results first posted
- 2017-08-02
- Limitations and caveats
- High percentage of patients lost to follow up
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Menses During the Six Month Study Period. | Up to 6 months | Ovulatory cycles will be confirmed by serum progesterone levels. |
| Secondary | Change in Insulin Resistance | Baseline and 6 months | 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). |
| Secondary | Change in Glucose Response | Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Menses During the Six Month Study Period. | Up to 6 months | Number of menstrual cycles per month | MEDIAN | |
| SECONDARY | Change in Insulin Resistance | Baseline and 6 months | Insulin sensitivity indices | MEDIAN | |
| SECONDARY | Change in Glucose Response | Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion | mg/dL*min | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Menses During the Six Month Study Period. | Cinnamon Extract Arm | Baseline | .42 | Inter-Quartile Range .33 to .63 | Number of menstrual cycles per month |
| Number of Menses During the Six Month Study Period. | Placebo Arm | Baseline | .42 | Inter-Quartile Range .29 to .68 | Number of menstrual cycles per month |
| Number of Menses During the Six Month Study Period. | Cinnamon Extract Arm | Study Period | .75 | Inter-Quartile Range .5 to .83 | Number of menstrual cycles per month |
| Number of Menses During the Six Month Study Period. | Placebo Arm | Study Period | .25 | Inter-Quartile Range 0 to .54 | Number of menstrual cycles per month |
| Change in Insulin Resistance | Cinnamon Extract Arm | Homeostasis Model of Insulin Resistance - Baseline | 2.3 | Inter-Quartile Range 1.4 to 2.8 | Insulin sensitivity indices |
| Change in Insulin Resistance | Placebo Arm | Homeostasis Model of Insulin Resistance - Baseline | 1.8 | Inter-Quartile Range .71 to 3.3 | Insulin sensitivity indices |
| Change in Insulin Resistance | Cinnamon Extract Arm | Homeostasis Model of Insulin Resistance - 6 months | 2.5 | Inter-Quartile Range .97 to 3.3 | Insulin sensitivity indices |
| Change in Insulin Resistance | Placebo Arm | Homeostasis Model of Insulin Resistance - 6 months | 1.2 | Inter-Quartile Range .78 to 2.6 | Insulin sensitivity indices |
| Change in Insulin Resistance | Cinnamon Extract Arm | Quant. Insulin Sensitivity Check Index - Baseline | .34 | Inter-Quartile Range .33 to .36 | Insulin sensitivity indices |
| Change in Insulin Resistance | Placebo Arm | Quant. Insulin Sensitivity Check Index - Baseline | .35 | Inter-Quartile Range .32 to .41 | Insulin sensitivity indices |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cinnamon Extract Arm | 23 | |
| Overall Study | STARTED | Placebo Arm | 22 | |
| Overall Study | Completed 3 Months | Cinnamon Extract Arm | 15 | |
| Overall Study | Completed 3 Months | Placebo Arm | 11 | |
| Overall Study | COMPLETED | Cinnamon Extract Arm | 11 | |
| Overall Study | COMPLETED | Placebo Arm | 6 | |
| Overall Study | NOT COMPLETED | Cinnamon Extract Arm | 12 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 16 |
Source ClinicalTrials.gov
Adverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acid reflux | Gastrointestinal disorders | Cinnamon Extract Arm | 1 | 23 | 1 |
| other | Acid reflux | Gastrointestinal disorders | Placebo Arm | 0 | 22 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Cinnamon Extract Arm | 0 | 23 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Placebo Arm | 1 | 22 | 1 |
| other | Anxiety | General disorders | Cinnamon Extract Arm | 1 | 23 | 1 |
| other | Anxiety | General disorders | Placebo Arm | 0 | 22 | 0 |
| other | Back pain | General disorders | Cinnamon Extract Arm | 3 | 23 | 11 |
| other | Back pain | General disorders | Placebo Arm | 1 | 22 | 1 |
| other | Bodyache | General disorders | Cinnamon Extract Arm | 1 | 23 | 1 |
| other | Bodyache | General disorders | Placebo Arm | 0 | 22 | 0 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cinnamon Extract Arm | ||
| Total, all-cause mortality | Placebo Arm | ||
| Total, other adverse events | Cinnamon Extract Arm | 15 | 23 |
| Total, other adverse events | Placebo Arm | 13 | 22 |
| Total, serious adverse events | Cinnamon Extract Arm | 1 | 23 |
| Total, serious adverse events | Placebo Arm | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24813595 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cinnamon Extract Arm vs Placebo Arm: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01483118
GET https://conductscience.org/api/trials/v1/NCT01483118/events?page=2