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

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483118
• Other study ID #: AAAI1377
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2011
• Last updated: September 5, 2017
• Start date: March 2011
• Est. completion date: April 2014

Study information

• Verified date: June 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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).

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Cinnamon Extract
Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.

Dietary Supplement:
• Placebo
Placebo capsules containing ground cereal.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rogerio A. Lobo	Integrity Nutraceuticals International

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Menses During the Six Month Study Period.	Ovulatory cycles will be confirmed by serum progesterone levels.	Up to 6 months
Secondary	Change in Insulin Resistance	The changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of >2 is considered healthy for adults with scores >5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes).	Baseline and 6 months
Secondary	Change in Glucose Response	Change in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion.	Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion