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

This study has been completed.
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 7, 2017
Last verified: June 2017
November 29, 2011
July 7, 2017
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 ]
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 ]
    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. For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes.
  • Change in Glucose Response [ Time Frame: Up to 6 Months ]
    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 compraed to the corresponding change in patient receiving 6 months of placebo.
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.
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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
    PCOS patients receiving abstract of cinnamon
    Intervention: Drug: Cinnamon Extract
  • Placebo Comparator: Placebo Arm
    PCOS patients receiving placebo capsules
    Intervention: Dietary Supplement: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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).
Sexes Eligible for Study: Female
18 Years to 38 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01483118
AAAI1377
Yes
Not Provided
Plan to Share IPD: Undecided
Rogerio A. Lobo, Columbia University
Rogerio A. Lobo
Integrity Nutraceuticals International
Principal Investigator: Rogerio Lobo, MD Columbia University
Columbia University
June 2017

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