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

November 29, 2011
July 29, 2013
March 2011
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01483118 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • 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.
  • Active Comparator: Cinnamon Extract Arm
    Purified aqueous abstract of cinnamon in 125mg capsules
    Intervention: Drug: Cinnamon Extract
  • Placebo Comparator: Placebo Arm
    Placebo capsules containing ground cereal.
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
April 2014
May 2013   (final data collection date for primary outcome measure)

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).
Female
18 Years to 38 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01483118
AAAI1377
Yes
Rogerio A. Lobo, Columbia University
Rogerio A. Lobo
Integrity Nutraceuticals International
Principal Investigator: Rogerio Lobo, MD Columbia University
Columbia University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP