The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Ovary Syndrome |
Drug: Oral Cinnamon Extract Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study |
- Fasting glucose [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Fasting insulin [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- HOMA-IR [ Time Frame: Up to 8 weeks after treatment ] [ Designated as safety issue: No ]
- QUICKI [ Time Frame: Up to 8 weeks after treatment ] [ Designated as safety issue: No ]
- Insulin sensitivity index (Matsuda) [ Time Frame: Up to 8 weeks after treatment ] [ Designated as safety issue: No ]
- Total testosterone [ Time Frame: Up to 8 weeks after treatment ] [ Designated as safety issue: No ]
- Sex hormbone binding globulin [ Time Frame: Up to 8 weeks after treatment ] [ Designated as safety issue: No ]
| Enrollment: | 1 |
| Study Start Date: | August 2005 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cinnamon Extract
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.
|
Drug: Oral Cinnamon Extract
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.
Other Name: Cinnamon Extract
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo pills in likeness of the cinnamon extract
Other Name: Placebo
|
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.
Eligibility| Ages Eligible for Study: | 23 Years to 47 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Polycystic ovary syndrome
Exclusion Criteria:
- Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
Contacts and Locations| United States, New York | |
| Center for Women's Reproductive Care | |
| New York, New York, United States, 10019 | |
| Principal Investigator: | Rogerio Lobo, M.D. | Columbia University |
More Information
No publications provided
| Responsible Party: | Rogerio A. Lobo, Professor, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00331279 History of Changes |
| Other Study ID Numbers: | AAAA8837 |
| Study First Received: | May 25, 2006 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Columbia University:
|
polycystic ovary syndrome insulin resistance cinnamon |
Additional relevant MeSH terms:
|
Insulin Resistance Polycystic Ovary Syndrome Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013