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

• ClinicalTrials.gov Identifier: NCT01483118
• Recruitment Status: Completed
• First Posted: December 1, 2011
• Results First Posted: August 2, 2017
• Last Update Posted: October 3, 2017
• Sponsor: Rogerio A. Lobo
• Collaborator: Integrity Nutraceuticals International
• Information provided by (Responsible Party): Rogerio A. Lobo, Columbia University

Tracking Information

• First Submitted Date: November 29, 2011
• First Posted Date: December 1, 2011
• Results First Submitted Date: May 26, 2016
• Results First Posted Date: August 2, 2017
• Last Update Posted Date: October 3, 2017
• Study Start Date: March 2011
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 7, 2017)

Number of Menses During the Six Month Study Period. [ Time Frame: Up to 6 months ]

Ovulatory cycles will be confirmed by serum progesterone levels.

Original Primary Outcome Measures (submitted: November 30, 2011)

Number of menses during the six month study period. [ Time Frame: Up to 6 months ]

Ovulatory cycles will be confirmed by serum progesterone levels.

Current Secondary Outcome Measures (submitted: September 5, 2017)

• Change in Insulin Resistance [ Time Frame: Baseline and 6 months ]
  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).
• Change in Glucose Response [ Time Frame: Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion ]
  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.

Original Secondary Outcome Measures (submitted: November 30, 2011)

Change in insulin resistance [ Time Frame: Up to 6 months ]

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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Polycystic Ovary 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.
  Other Name: Cinnulin PF
• Dietary Supplement: Placebo
  Placebo capsules containing ground cereal.

Study Arms

• Active Comparator: Cinnamon Extract Arm
  PCOS patients receiving abstract of cinnamon
  Intervention: Drug: Cinnamon Extract
• Placebo Comparator: Placebo Arm
  PCOS patients receiving placebo capsules
  Intervention: Dietary Supplement: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2013): 45
• Original Estimated Enrollment (submitted: November 30, 2011): 60
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 38 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01483118
• Other Study ID Numbers: AAAI1377
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Rogerio A. Lobo, Columbia University
• Original Responsible Party: Columbia University
• Current Study Sponsor: Rogerio A. Lobo
• Original Study Sponsor: Columbia University
• Collaborators: Integrity Nutraceuticals International

Investigators

• Principal Investigator: Rogerio Lobo, MD; Columbia University

• PRS Account: Columbia University
• Verification Date: June 2017