Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)

Completed · Phase 3 · Has a placebo group

Conditions studied: Polycystic Ovary Syndrome

In brief

The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin resistance in larger group of study subjects. 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. 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. Our own study also showed that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The purpose of this study is to see if cinnamon can help women with PCOS have more regular periods.

Key facts

Study ID

NCT01483118

Run by

Rogerio A. Lobo

People needed

45

Starts

2011-03-01

Expected to finish

2014-04-01

Last updated by the study team

2017-10-03

Who can join

Age: 18 and older, up to 38. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged greater than 18 years of age
• Ability to understand and willingness to comply with the study protocol
• Written informed consent
• Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries.

You may not qualify if…

• Current pregnancy or lactation
• Liver disease or elevated liver enzymes
• Established diagnosis of diabetes mellitus
• Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association.
• Insulin sensitizing treatment within 3 months prior to or during the eight week study period.
• Hormonal treatment involving estrogen or progesterone 3 months prior to or during the study period, with the exception of medroxyprogesterone acetate for withdrawal bleeding.
• Systemic or inhaled corticosteroids.
• Known hypersensitive reaction to cinnamon.
• Patients with seizure disorders, known cardiovascular disease, or cerebrovascular disease.
• Body mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50).

Where it is running

• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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