The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral Cinnamon Extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, insulin resistance, cinnamon
Eligibility Criteria
Inclusion Criteria: Polycystic ovary syndrome Exclusion Criteria: Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
Sites / Locations
- Center for Women's Reproductive Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cinnamon Extract
Placebo
Arm Description
A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.
Outcomes
Primary Outcome Measures
Fasting glucose
Fasting insulin
HOMA-IR
QUICKI
Insulin sensitivity index (Matsuda)
Secondary Outcome Measures
Total testosterone
Sex hormbone binding globulin
Full Information
NCT ID
NCT00331279
First Posted
May 25, 2006
Last Updated
December 6, 2012
Sponsor
Columbia University
Collaborators
USDA Beltsville Human Nutrition Research Center, Integrity Neutraceuticals, Inc. Sarasota, FL
1. Study Identification
Unique Protocol Identification Number
NCT00331279
Brief Title
The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
Official Title
The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
USDA Beltsville Human Nutrition Research Center, Integrity Neutraceuticals, Inc. Sarasota, FL
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome.
Detailed Description
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.
Medications that lower the body's insulin level used to treat people with diabetes mellitus have also been used very successfully to treat some of the symptoms of PCOS such as irregular periods.
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. The purpose of this study is to see if cinnamon can lower the insulin level in women with PCOS. If so, it can also be used as a treatment for irregular periods as well.
Half of the patients in the study will take premade cinnamon extract pills twice a day while the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight weeks. Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the eight weeks of medication. A total of three separate visits will be needed to finish the study. At the end of the study, we will then compare the 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
polycystic ovary syndrome, insulin resistance, cinnamon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cinnamon Extract
Arm Type
Active Comparator
Arm Description
A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oral Cinnamon Extract
Other Intervention Name(s)
Cinnamon Extract
Intervention Description
A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pills in likeness of the cinnamon extract
Primary Outcome Measure Information:
Title
Fasting glucose
Time Frame
Duration of study
Title
Fasting insulin
Time Frame
Duration of study
Title
HOMA-IR
Time Frame
Up to 8 weeks after treatment
Title
QUICKI
Time Frame
Up to 8 weeks after treatment
Title
Insulin sensitivity index (Matsuda)
Time Frame
Up to 8 weeks after treatment
Secondary Outcome Measure Information:
Title
Total testosterone
Time Frame
Up to 8 weeks after treatment
Title
Sex hormbone binding globulin
Time Frame
Up to 8 weeks after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Polycystic ovary syndrome
Exclusion Criteria:
Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogerio Lobo, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Women's Reproductive Care
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
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