The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
NCT ID: NCT00331279
Last Updated: 2012-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
1 participants
INTERVENTIONAL
2005-08-31
2006-02-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Oral 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.
Placebo
Placebo
Placebo pills in likeness of the cinnamon extract
Interventions
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Oral 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.
Placebo
Placebo pills in likeness of the cinnamon extract
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
23 Years
47 Years
FEMALE
Yes
Sponsors
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USDA Beltsville Human Nutrition Research Center
FED
Integrity Neutraceuticals, Inc. Sarasota, FL
INDUSTRY
Columbia University
OTHER
Responsible Party
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Rogerio A. Lobo
Professor
Principal Investigators
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Rogerio Lobo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Center for Women's Reproductive Care
New York, New York, United States
Countries
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Other Identifiers
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AAAA8837
Identifier Type: -
Identifier Source: org_study_id