The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study

Official Title: “The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot 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.

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.

Intervention(s) in this Clinical Trial

• Drug: 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.
• Drug: Placebo
  • Placebo pills in likeness of the cinnamon extract

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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 Comparator: Placebo

Primary Measures

• Fasting glucose
  • Time Frame: Duration of study
    Safety Issue?: No
• Fasting insulin
  • Time Frame: Duration of study
    Safety Issue?: No
• HOMA-IR
  • Time Frame: Up to 8 weeks after treatment
    Safety Issue?: No
• QUICKI
  • Time Frame: Up to 8 weeks after treatment
    Safety Issue?: No
• Insulin sensitivity index (Matsuda)
  • Time Frame: Up to 8 weeks after treatment
    Safety Issue?: No

Secondary Measures

• Total testosterone
  • Time Frame: Up to 8 weeks after treatment
    Safety Issue?: No
• Sex hormbone binding globulin
  • Time Frame: Up to 8 weeks after treatment
    Safety Issue?: No

Inclusion Criteria:

• Polycystic ovary syndrome

Exclusion Criteria:

• Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 23 Years

Maximum Age for this Clinical Trial: 47 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Columbia University Other

Overall Clinical Trial Officials and Contacts

Rogerio Lobo, M.D. Principal Investigator Columbia University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00331279

Study ID Number: AAAA8837

ClinicalTrials.gov Identifier: NCT00331279

Health Authority: United States: Institutional Review Board