Back to resultsEffect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome (Eccentric)
Primary Purpose
Polycystic Ovary Syndrome, Insulin Resistance
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cinnamon Supplementation
Placebo (wheat flour)
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Cinnamon, PCOS, low blood sugar, Insulin, Glucose
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cinnamon Supplementation
Placebo
Arm Description
A 500mg (consumed as two, 250mg capsules) of cinnamon extract (Cinnamon Bark P.E> 20:1) will be consumed before meals, three times per day.
A 500 mg placebo (wheat flour) will be consumed before meals, three times per day.
Outcomes
Primary Outcome Measures
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
Secondary Outcome Measures
Full Information
NCT ID
NCT00970541
First Posted
August 31, 2009
Last Updated
August 23, 2021
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00970541
Brief Title
Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome
Acronym
Eccentric
Official Title
Phase 1 Study That Will Compare 12 Weeks of Supplementation With Cinnamon Extract on the Action of Insulin and Blood Sugar (Glucose) With 12 Weeks of Supplementation With a Placebo.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment
Study Start Date
August 2009 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 become abnormally high. Insulin resistance is common in women with polycystic ovary syndrome (PCOS). This study involves the administration of a nutritional supplement (cinnamon extract). The cinnamon extract like regular cinnamon powder comes from the bark of Cinnamon Cassae plant. It is believed that cinnamon may act in the same way as insulin and therefore could potentially improve insulin resistance and help to lower blood sugar (glucose) levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Insulin Resistance
Keywords
Cinnamon, PCOS, low blood sugar, Insulin, Glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cinnamon Supplementation
Arm Type
Active Comparator
Arm Description
A 500mg (consumed as two, 250mg capsules) of cinnamon extract (Cinnamon Bark P.E> 20:1) will be consumed before meals, three times per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A 500 mg placebo (wheat flour) will be consumed before meals, three times per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cinnamon Supplementation
Other Intervention Name(s)
The bark of Cinnamoni Cassae
Intervention Description
1, 3, or 6g of cinnamon per day for 40 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (wheat flour)
Other Intervention Name(s)
500mg placebo (wheat flour) will be cnsumed before meals, three times per day.
Intervention Description
1, 3, or 6g of placebo per day for 40 days
Primary Outcome Measure Information:
Title
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Redman, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
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Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome
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