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

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Cinnamon Extract

Placebo

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Insulin resistance, Cinnamon extract, Irregular menstrual cycles, Ovarian cysts

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cinnamon Extract Arm

Placebo Arm

Arm Description

PCOS patients receiving abstract of cinnamon

PCOS patients receiving placebo capsules

Outcomes

Primary Outcome Measures

Number of Menses During the Six Month Study Period.

Ovulatory cycles will be confirmed by serum progesterone levels.

Secondary Outcome Measures

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).

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.

Full Information

NCT ID

NCT01483118

First Posted

November 29, 2011

Last Updated

September 5, 2017

Sponsor

Rogerio A. Lobo

Collaborators

Integrity Nutraceuticals International

1. Study Identification

Unique Protocol Identification Number

NCT01483118

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rogerio A. Lobo

Collaborators

Integrity Nutraceuticals International

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

PCOS, Insulin resistance, Cinnamon extract, Irregular menstrual cycles, Ovarian cysts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cinnamon Extract Arm

Arm Type

Active Comparator

Arm Description

PCOS patients receiving abstract of cinnamon

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

PCOS patients receiving placebo capsules

Intervention Type

Drug

Intervention Name(s)

Cinnamon Extract

Other Intervention Name(s)

Cinnulin PF

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules containing ground cereal.

Primary Outcome Measure Information:

Title

Number of Menses During the Six Month Study Period.

Description

Ovulatory cycles will be confirmed by serum progesterone levels.

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Change in Insulin Resistance

Description

Time Frame

Baseline and 6 months

Title

Change in Glucose Response

Description

Time Frame

Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rogerio Lobo, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

24813595

Citation

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.

Results Reference

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

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