The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study

This study has been completed.
Sponsor:
Collaborators:
USDA Beltsville Human Nutrition Research Center
Integrity Neutraceuticals, Inc. Sarasota, FL
Information provided by (Responsible Party):
Rogerio A. Lobo, Columbia University
ClinicalTrials.gov Identifier:
NCT00331279
First received: May 25, 2006
Last updated: December 6, 2012
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Polycystic ovary syndrome

Exclusion Criteria:

  • Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331279

Locations
United States, New York
Center for Women's Reproductive Care
New York, New York, United States, 10019
Sponsors and Collaborators
Columbia University
USDA Beltsville Human Nutrition Research Center
Integrity Neutraceuticals, Inc. Sarasota, FL
Investigators
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 April 16, 2014