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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Integrity Nutraceuticals International
Information provided by (Responsible Party):
Rogerio A. Lobo, Columbia University
ClinicalTrials.gov Identifier:
NCT01483118
First received: November 29, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.

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.


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Cinnamon Extract
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of menses during the six month study period. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Ovulatory cycles will be confirmed by serum progesterone levels.


Secondary Outcome Measures:
  • Change in insulin resistance [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cinnamon Extract Arm
Purified aqueous abstract of cinnamon in 125mg capsules
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
Placebo Comparator: Placebo Arm
Placebo capsules containing ground cereal.
Dietary Supplement: Placebo
Placebo capsules containing ground cereal.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483118

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Rogerio A. Lobo
Integrity Nutraceuticals International
Investigators
Principal Investigator: Rogerio Lobo, MD Columbia University
  More Information

No publications provided

Responsible Party: Rogerio A. Lobo, Professor of Obstetrics and Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT01483118     History of Changes
Other Study ID Numbers: AAAI1377
Study First Received: November 29, 2011
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
PCOS
Insulin resistance
Cinnamon extract
Irregular menstrual cycles
Ovarian cysts

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 10, 2014