Clinical trial NCT01483118: Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Official title: The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Insulin resistance
Cinnamon extract
Irregular menstrual cycles
Ovarian cysts
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Integrity Nutraceuticals International
First posted: 2011-12-01
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Menses During the Six Month Study Period.
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in Insulin Resistance
timeFrame: Baseline and 6 months
measure: Change in Glucose Response
timeFrame: Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rogerio Lobo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kort DH, Lobo RA. Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial. Am J Obstet Gynecol. 2014 Nov;211(5):487.e1-6. doi: 10.1016/j.ajog.2014.05.009. Epub 2014 May 9.