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NCT Number: NCT00331279

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Polycystic ovary syndrome

Exclusion criteria

  • Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

Treatment and study plan

Oral Cinnamon Extract

Drug

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.

Other names: Cinnamon Extract

Placebo

Drug

Placebo pills in likeness of the cinnamon extract

Primary outcomes

  1. Fasting glucose

    Time frame: Duration of study

  2. Fasting insulin

    Time frame: Duration of study

  3. HOMA-IR

    Time frame: Up to 8 weeks after treatment

  4. QUICKI

    Time frame: Up to 8 weeks after treatment

  5. Insulin sensitivity index (Matsuda)

    Time frame: Up to 8 weeks after treatment

Secondary outcomes

  1. Total testosterone

    Time frame: Up to 8 weeks after treatment

  2. Sex hormbone binding globulin

    Time frame: Up to 8 weeks after treatment

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Integrity Neutraceuticals, Inc. Sarasota, FL
  • USDA Beltsville Human Nutrition Research Center

Registry information

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
May 29, 2006
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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