The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2005
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 25, 2006
CompletedFirst Posted
Study publicly available on registry
May 29, 2006
CompletedDecember 10, 2012
January 1, 2011
1 month
May 25, 2006
December 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Fasting glucose
Duration of study
Fasting insulin
Duration of study
HOMA-IR
Up to 8 weeks after treatment
QUICKI
Up to 8 weeks after treatment
Insulin sensitivity index (Matsuda)
Up to 8 weeks after treatment
Secondary Outcomes (2)
Total testosterone
Up to 8 weeks after treatment
Sex hormbone binding globulin
Up to 8 weeks after treatment
Study Arms (2)
Cinnamon Extract
ACTIVE COMPARATORA 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.
Placebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Polycystic ovary syndrome
You may not qualify if:
- Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- USDA Beltsville Human Nutrition Research Centercollaborator
- Integrity Neutraceuticals, Inc. Sarasota, FLcollaborator
Study Sites (1)
Center for Women's Reproductive Care
New York, New York, 10019, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rogerio Lobo, M.D.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 25, 2006
First Posted
May 29, 2006
Study Start
August 1, 2005
Primary Completion
September 1, 2005
Study Completion
February 1, 2006
Last Updated
December 10, 2012
Record last verified: 2011-01