Polycystic Ovary SyndromePhase 1EccentricNCT00970541
Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome
A Phase 1 study testing Cinnamon Supplementation in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance
- What is being tested?
- Cinnamon Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2013
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20 to 40 years of age
- Have a body mass index 25-40 kg/m2
- Have a sedentary lifestyle (participated in less than 30 minutes of physical activity 3 days per week over the last 6 months)
- History of irregular menstrual cycles (fewer than 6 cycles in past year)
- Excess androgen (to be measured at screening)
- Willing to supplement normal diet with cinnamon extract and a placebo for 12 weeks
- You can stay overnight at Pennington Center three times over the next six months
Who cannot join
- Do not meet our diagnostic criteria for polycystic ovary syndrome
- Have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
- Have cancer (active malignancy with or without concurrent chemotherapy).
- Abuse alcohol or illegal drugs.
- Smoke or have smoked within the previous 6 months. No smoking will be permitted during the study.
- Have donated blood within 30 days prior to randomization date.
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- Have a hemoglobin, hematocrit, red blood cell, or iron level below the normal lower limit at screening.
- Taking medications that alter your glucose metabolism, (30 minute or more, 4 or more times per week over the past year.)
- Unwilling or unable to adhere to the clinical evaluation schedule over the entire six-month follow-up period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Phase 1 Study That Will Compare 12 Weeks of Supplementation With Cinnamon Extract on the Action of Insulin and Blood Sugar (Glucose) With 12 Weeks of Supplementation With a Placebo.
The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels.
Read the detailed description
Insulin resistance is a condition in which body cells do not fully respond to the action of insulin, a hormone that controls the amount of sugar (glucose) in the blood. As a result, blood sugar levels become abnormally high. Insulin resistance is common in women with polycystic ovary syndrome (PCOS). This study involves the administration of a nutritional supplement (cinnamon extract). The cinnamon extract like regular cinnamon powder comes from the bark of Cinnamon Cassae plant. It is believed that cinnamon may act in the same way as insulin and therefore could potentially improve insulin resistance and help to lower blood sugar (glucose) levels.
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Being tested
- Cinnamon Supplementation, Placebo (wheat flour)
- Keywords
- Cinnamon, PCOS, low blood sugar, Insulin, Glucose
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamon SupplementationDietary supplement
Also called The bark of Cinnamoni Cassae
1, 3, or 6g of cinnamon per day for 40 days
Placebo (wheat flour)Dietary supplement
Also called 500mg placebo (wheat flour) will be cnsumed before meals, three times per day.
1, 3, or 6g of placebo per day for 40 days
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon Supplementation | Active comparator | A 500mg (consumed as two, 250mg capsules) of cinnamon extract (Cinnamon Bark P.E> 20:1) will be consumed before meals, three times per day. Receives: Dietary Supplement: Cinnamon Supplementation |
| Placebo | Placebo comparator | A 500 mg placebo (wheat flour) will be consumed before meals, three times per day. Receives: Dietary Supplement: Placebo (wheat flour) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Recruitment
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.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne Redman, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970541
- Sponsor's protocol ID
- PBRC 29010
- Acronym
- Eccentric
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2009
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study That Will Compare 12 Weeks of Supplementation With Cinnamon Extract on the Action of Insulin and Blood Sugar (Glucose) With 12 Weeks of Supplementation With a Placebo.
- ClinicalTrials.gov ID
- NCT00970541
- Acronym / sponsor ID
- Eccentric / PBRC 29010
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Keywords
- Cinnamon, PCOS, low blood sugar, Insulin, Glucose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Sep 2009 (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 Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels.
Detailed description
Insulin resistance is a condition in which body cells do not fully respond to the action of insulin, a hormone that controls the amount of sugar (glucose) in the blood. As a result, blood sugar levels become abnormally high. Insulin resistance is common in women with polycystic ovary syndrome (PCOS). This study involves the administration of a nutritional supplement (cinnamon extract). The cinnamon extract like regular cinnamon powder comes from the bark of Cinnamon Cassae plant. It is believed that cinnamon may act in the same way as insulin and therefore could potentially improve insulin resistance and help to lower blood sugar (glucose) levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon Supplementation | Active comparator | Dietary Supplement: Cinnamon SupplementationA 500mg (consumed as two, 250mg capsules) of cinnamon extract (Cinnamon Bark P.E> 20:1) will be consumed before meals, three times per day. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (wheat flour)A 500 mg placebo (wheat flour) will be consumed before meals, three times per day. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 20 to 40 years of age
- Have a body mass index 25-40 kg/m2
- Have a sedentary lifestyle (participated in less than 30 minutes of physical activity 3 days per week over the last 6 months)
- History of irregular menstrual cycles (fewer than 6 cycles in past year)
- Excess androgen (to be measured at screening)
Key exclusion criteria (9 listed)
- Do not meet our diagnostic criteria for polycystic ovary syndrome
- Have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
- Have cancer (active malignancy with or without concurrent chemotherapy).
- Abuse alcohol or illegal drugs.
- Smoke or have smoked within the previous 6 months. No smoking will be permitted during the study.
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 SupplementationAlso: The bark of Cinnamoni Cassae1, 3, or 6g of cinnamon per day for 40 days | Dietary supplement | Cinnamon Supplementation |
| Placebo (wheat flour)Also: 500mg placebo (wheat flour) will be cnsumed before meals, three times per day.1, 3, or 6g of placebo per day for 40 days | Dietary supplement | Placebo |
Primary outcome
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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.
Leanne Redman, PhD principal investigator
Pennington Biomedical Research Center
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 Cinnamon Supplementation in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Pennington Biomedical Research Center 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Aug 2021. 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 was stopped early (reason given: Recruitment). Results are not available in the source record.
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?
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp (time frame: 6 months). 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 25 Aug 2021.