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

Phase 1

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Oral Cinnamon Extract

• Registration Number: NCT00331279
• Lead Sponsor: Columbia University

Brief 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.

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 Timeline

• Study Start: 2005-08
• Primary Completion: 2005-09
• Study Completion: 2006-02
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-25
• Study First Posted: 2006-05-29
• Status Verified: 2011-01
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

• Polycystic ovary syndrome

Exclusion Criteria

• Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cinnamon Extract	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.

Primary Outcome Measures

Name	Time	Method
Fasting glucose	Duration of study
Fasting insulin	Duration of study
HOMA-IR	Up to 8 weeks after treatment
QUICKI	Up to 8 weeks after treatment
Insulin sensitivity index (Matsuda)	Up to 8 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Total testosterone	Up to 8 weeks after treatment
Sex hormbone binding globulin	Up to 8 weeks after treatment

Trial Locations

Locations (1)

Center for Women's Reproductive Care; 🇺🇸 New York, New York, United States