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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331279
• Other study ID #: AAAA8837
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2006
• Last updated: December 6, 2012
• Start date: August 2005
• Est. completion date: February 2006

Study information

• Verified date: January 2011
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 47 Years

Eligibility

Inclusion Criteria:

• Polycystic ovary syndrome

Exclusion Criteria:

• Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• Placebo
Placebo pills in likeness of the cinnamon extract

Locations

Country	Name	City	State
United States	Center for Women's Reproductive Care	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Integrity Neutraceuticals, Inc. Sarasota, FL, USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose		Duration of study	No
Primary	Fasting insulin		Duration of study	No
Primary	HOMA-IR		Up to 8 weeks after treatment	No
Primary	QUICKI		Up to 8 weeks after treatment	No
Primary	Insulin sensitivity index (Matsuda)		Up to 8 weeks after treatment	No
Secondary	Total testosterone		Up to 8 weeks after treatment	No
Secondary	Sex hormbone binding globulin		Up to 8 weeks after treatment	No