Polycystic Ovary SyndromePhase 1NCT00331279
The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
A Phase 1 study testing Oral Cinnamon Extract in people with Polycystic Ovary Syndrome, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 23 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Oral Cinnamon Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Feb 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 23 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Polycystic ovary syndrome
Who cannot join
- Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Women's Reproductive Care
New York, New York, 10019
About this study
The purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome.
Read the detailed description
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.
Medications that lower the body's insulin level used to treat people with diabetes mellitus have also been used very successfully to treat some of the symptoms of PCOS such as irregular periods.
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. The purpose of this study is to see if cinnamon can lower the insulin level in women with PCOS. If so, it can also be used as a treatment for irregular periods as well.
Half of the patients in the study will take premade cinnamon extract pills twice a day while the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight weeks. Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the eight weeks of medication. A total of three separate visits will be needed to finish the study. At the end of the study, we will then compare the blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Oral Cinnamon Extract, Placebo
- Keywords
- polycystic ovary syndrome, insulin resistance, cinnamon
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Cinnamon ExtractDrug
Also called Cinnamon Extract
A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.
PlaceboDrug
Placebo pills in likeness of the cinnamon extract
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon Extract | Active comparator | A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks. Receives: Drug: Oral Cinnamon Extract |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Measured: Duration of study
Fasting insulin
Measured: Duration of study
HOMA-IR
Measured: Up to 8 weeks after treatment
QUICKI
Measured: Up to 8 weeks after treatment
Insulin sensitivity index (Matsuda)
Measured: Up to 8 weeks after treatment
Secondary outcomes (2)
Total testosterone
Measured: Up to 8 weeks after treatment
Sex hormbone binding globulin
Measured: Up to 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center, Integrity Neutraceuticals, Inc. Sarasota, FL
- Responsible party
- Principal investigator, Rogerio A. Lobo, Columbia University
- Investigators
- Rogerio Lobo, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331279
- Sponsor's protocol ID
- AAAA8837
- Status last verified
- Jan 2011
- First submitted
- 25 May 2006
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT00331279
- Acronym / sponsor ID
- AAAA8837
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, insulin resistance, cinnamon
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center, Integrity Neutraceuticals, Inc. Sarasota, FL
- Study start
- Aug 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 29 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome.
Detailed description
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.
Medications that lower the body's insulin level used to treat people with diabetes mellitus have also been used very successfully to treat some of the symptoms of PCOS such as irregular periods.
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. The purpose of this study is to see if cinnamon can lower the insulin level in women with PCOS. If so, it can also be used as a treatment for irregular periods as well.
Half of the patients in the study will take premade cinnamon extract pills twice a day while the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight weeks. Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the eight weeks of medication. A total of three separate visits will be needed to finish the study. At the end of the study, we will then compare the 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
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon Extract | Active comparator | Drug: Oral Cinnamon ExtractA purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 23 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Polycystic ovary syndrome
Key exclusion criteria (1 listed)
- Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
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 |
|---|---|---|
| Oral Cinnamon ExtractAlso: Cinnamon ExtractA purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks. | Drug | Cinnamon Extract |
| PlaceboPlacebo pills in likeness of the cinnamon extract | Drug | Placebo |
Primary outcome
Fasting glucose
Time frame: Duration of study
Fasting insulin
Time frame: Duration of study
HOMA-IR
Time frame: Up to 8 weeks after treatment
QUICKI
Time frame: Up to 8 weeks after treatment
Insulin sensitivity index (Matsuda)
Time frame: Up to 8 weeks after treatment
2 secondary outcomes
Total testosterone
Time frame: Up to 8 weeks after treatment
Sex hormbone binding globulin
Time frame: Up to 8 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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, M.D. 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 1 study testing Oral Cinnamon Extract in people with Polycystic Ovary Syndrome, run by Columbia University 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 1 inclusion and 1 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 10 Dec 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fasting glucose (time frame: Duration of study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2012.