Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 38 |
| Updated: | 10/5/2017 |
| Start Date: | March 2011 |
| End Date: | April 2014 |
The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome
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.
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.
All patients will eat a balanced diet containing 1800 calories per day, but half of the
patients in the study will take pre-made cinnamon extract pills three times a day, while the
other half will take placebo pills (pills with no cinnamon extract) three times a day for 6
months. During this time, every patient will keep track of her period on a calendar.
Blood tests measuring insulin, substances important for insulin action, cholesterol, and
glucose (sugar) will be taken before and after the 6 months of medication. A total of 8
separate visits will be needed to finish the study. At the end of the study, the
investigators will then compare the number of periods, blood glucose, insulin, and
cholesterol levels between the patients that took cinnamon and the patients that took
placebo.
patients in the study will take pre-made cinnamon extract pills three times a day, while the
other half will take placebo pills (pills with no cinnamon extract) three times a day for 6
months. During this time, every patient will keep track of her period on a calendar.
Blood tests measuring insulin, substances important for insulin action, cholesterol, and
glucose (sugar) will be taken before and after the 6 months of medication. A total of 8
separate visits will be needed to finish the study. At the end of the study, the
investigators will then compare the number of periods, blood glucose, insulin, and
cholesterol levels between the patients that took cinnamon and the patients that took
placebo.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
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