Status:
TERMINATED
Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Polycystic Ovary Syndrome
Insulin Resistance
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels.
Detailed Description
Insulin resistance is a condition in which body cells do not fully respond to the action of insulin, a hormone that controls the amount of sugar (glucose) in the blood. As a result, blood sugar levels...
Eligibility Criteria
Inclusion
- 20 to 40 years of age
- Have a body mass index 25-40 kg/m2
- Have a sedentary lifestyle (participated in less than 30 minutes of physical activity 3 days per week over the last 6 months)
- History of irregular menstrual cycles (fewer than 6 cycles in past year)
- Excess androgen (to be measured at screening)
- Willing to supplement normal diet with cinnamon extract and a placebo for 12 weeks
- You can stay overnight at Pennington Center three times over the next six months
Exclusion
- Do not meet our diagnostic criteria for polycystic ovary syndrome
- Have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
- Have cancer (active malignancy with or without concurrent chemotherapy).
- Abuse alcohol or illegal drugs.
- Smoke or have smoked within the previous 6 months. No smoking will be permitted during the study.
- Have donated blood within 30 days prior to randomization date.
- Have a hemoglobin, hematocrit, red blood cell, or iron level below the normal lower limit at screening.
- Taking medications that alter your glucose metabolism, (30 minute or more, 4 or more times per week over the past year.)
- Unwilling or unable to adhere to the clinical evaluation schedule over the entire six-month follow-up period.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00970541
Start Date
August 1 2009
End Date
June 1 2013
Last Update
August 25 2021
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808