Polycystic Ovary SyndromePhase 3NCT01483118
Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
A Phase 3 study testing Cinnamon Extract in people with Polycystic Ovary Syndrome, run by Rogerio A. Lobo at 1 site in United States.
Trial summary
The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin resistance in larger group of study… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Cinnamon Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged greater than 18 years of age
- Ability to understand and willingness to comply with the study protocol
- Written informed consent
- Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries.
Who cannot join
- Current pregnancy or lactation
- Liver disease or elevated liver enzymes
- Established diagnosis of diabetes mellitus
- Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association.
- Insulin sensitizing treatment within 3 months prior to or during the eight week study period.
- Hormonal treatment involving estrogen or progesterone 3 months prior to or during the study period, with the exception of medroxyprogesterone acetate for withdrawal bleeding.
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- Systemic or inhaled corticosteroids.
- Known hypersensitive reaction to cinnamon.
- Patients with seizure disorders, known cardiovascular disease, or cerebrovascular disease.
- Body mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome
The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin resistance in larger group of study subjects.
Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. The syndrome can also be associated with more serious conditions such as heart disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome, scientific studies showed that having too much insulin can be one of the reasons. In fact, almost every overweight woman with PCOS has been found to have high insulin levels.
Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may also reduce the body's insulin level. Another study showed that daily use of cinnamon for forty days lowered the blood sugar level in patients with diabetes. Our own study also showed that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The purpose of this study is to see if cinnamon can help women with PCOS have more regular periods.
Read the detailed description
All patients will eat a balanced diet containing 1800 calories per day, but half of the patients in the study will take pre-made cinnamon extract pills three times a day, while the other half will take placebo pills (pills with no cinnamon extract) three times a day for 6 months. During this time, every patient will keep track of her period on a calendar.
Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the 6 months of medication. A total of 8 separate visits will be needed to finish the study. At the end of the study, the investigators will then compare the number of periods, blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Cinnamon Extract, Placebo
- Keywords
- PCOS, Insulin resistance, Cinnamon extract, Irregular menstrual cycles, Ovarian cysts
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Menstruation Disturbances, Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamon ExtractDrug
Also called Cinnulin PF
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.
PlaceboDietary supplement
Placebo capsules containing ground cereal.
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon Extract Arm | Active comparator | PCOS patients receiving abstract of cinnamon Receives: Drug: Cinnamon Extract |
| Placebo Arm | Placebo comparator | PCOS patients receiving placebo capsules Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Menses During the Six Month Study Period.
Ovulatory cycles will be confirmed by serum progesterone levels.
Measured: Up to 6 months
Secondary outcomes (2)
Change in Insulin Resistance
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).
Measured: Baseline and 6 months
Change in Glucose Response
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.
Measured: Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rogerio A. Lobo
- Sponsor type
- University, hospital or other
- Collaborators
- Integrity Nutraceuticals International
- Responsible party
- Sponsor-investigator, Rogerio A. Lobo, Columbia University
- Investigators
- Rogerio Lobo, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483118
- Sponsor's protocol ID
- AAAI1377
- Status last verified
- Jun 2017
- First submitted
- 29 Nov 2011
- Last updated
- 3 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kort DH, Lobo RA. Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial. Am J Obstet Gynecol. 2014 Nov;211(5):487.e1-6. doi: 10.1016/j.ajog.2014.05.009. Epub 2014 May 9.
PubMed 24813595
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01483118
- Acronym / sponsor ID
- AAAI1377
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Insulin resistance, Cinnamon extract, Irregular menstrual cycles, Ovarian cysts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Rogerio A. LoboUniversity, hospital or other
- Collaborators
- Integrity Nutraceuticals International
- Study start
- Mar 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin resistance in larger group of study subjects.
Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. The syndrome can also be associated with more serious conditions such as heart disease, diabetes, or cancer of the uterus. Although no one knows the cause of the syndrome, scientific studies showed that having too much insulin can be one of the reasons. In fact, almost every overweight woman with PCOS has been found to have high insulin levels.
Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may also reduce the body's insulin level. Another study showed that daily use of cinnamon for forty days lowered the blood sugar level in patients with diabetes. Our own study also showed that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The purpose of this study is to see if cinnamon can help women with PCOS have more regular periods.
Detailed description
All patients will eat a balanced diet containing 1800 calories per day, but half of the patients in the study will take pre-made cinnamon extract pills three times a day, while the other half will take placebo pills (pills with no cinnamon extract) three times a day for 6 months. During this time, every patient will keep track of her period on a calendar.
Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the 6 months of medication. A total of 8 separate visits will be needed to finish the study. At the end of the study, the investigators will then compare the number of periods, blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon Extract Arm | Active comparator | Drug: Cinnamon ExtractPCOS patients receiving abstract of cinnamon |
| Placebo Arm | Placebo comparator | Dietary Supplement: PlaceboPCOS patients receiving placebo capsules |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged greater than 18 years of age
- Ability to understand and willingness to comply with the study protocol
- Written informed consent
- Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries.
Key exclusion criteria (10 listed)
- Current pregnancy or lactation
- Liver disease or elevated liver enzymes
- Established diagnosis of diabetes mellitus
- Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association.
- Insulin sensitizing treatment within 3 months prior to or during the eight week study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinnamon ExtractAlso: Cinnulin PFPurified 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. | Drug | Cinnamon Extract Arm |
| PlaceboPlacebo capsules containing ground cereal. | Dietary supplement | Placebo Arm |
Primary outcome
Number of Menses During the Six Month Study Period.
Time frame: Up to 6 months
Ovulatory cycles will be confirmed by serum progesterone levels.
2 secondary outcomes
Change in Insulin Resistance
Time frame: Baseline and 6 months
Change in Glucose Response
Time frame: Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24813595Kort DH, Lobo RA. Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial. Am J Obstet Gynecol. 2014 Nov;211(5):487.e1-6. doi: 10.1016/j.ajog.2014.05.009. Epub 2014 May 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogerio Lobo, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cinnamon Extract in people with Polycystic Ovary Syndrome, run by Rogerio A. Lobo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Menses During the Six Month Study Period. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01483118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.