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

This study has been completed.

Sponsors and Collaborators:	Columbia University United States Department of Agriculture Integrity Neutraceuticals, Inc. Sarasota, FL
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00331279

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	Phase I

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study

Further study details as provided by Columbia University:

Primary Outcome Measures:

Fasting glucose
Fasting insulin
HOMA-IR
QUICKI
Insulin sensitivity index (Matsuda)

Secondary Outcome Measures:

Total testosterone
Sex hormbone binding globulin

Estimated Enrollment:	12
Study Start Date:	August 2005
Estimated Study Completion Date:	February 2006

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

United States Department of Agriculture

Integrity Neutraceuticals, Inc. Sarasota, FL

Investigators

Principal Investigator:

Rogerio Lobo, M.D.

Columbia University

More Information

Study ID Numbers:	AAAA8837
Study First Received:	May 25, 2006
Last Updated:	May 25, 2006
ClinicalTrials.gov Identifier:	NCT00331279
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by Columbia University:

polycystic ovary syndrome
insulin resistance
cinnamon

Study placed in the following topic categories:

Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Cysts
Insulin
Genital Diseases, Female

Hyperinsulinism
Polycystic Ovary Syndrome
Insulin Resistance
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Ovarian Cysts

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Syndrome
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009