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Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome (Eccentric)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00970541
Recruitment Status : Terminated (Recruitment)
First Posted : September 2, 2009
Last Update Posted : October 28, 2019
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Insulin Resistance Dietary Supplement: Cinnamon Supplementation Dietary Supplement: Placebo (wheat flour) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Active Comparator: Cinnamon Supplementation
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.
Dietary Supplement: Cinnamon Supplementation
1, 3, or 6g of cinnamon per day for 40 days
Other Name: The bark of Cinnamoni Cassae

Placebo Comparator: Placebo
A 500 mg placebo (wheat flour) will be consumed before meals, three times per day.
Dietary Supplement: Placebo (wheat flour)
1, 3, or 6g of placebo per day for 40 days
Other Name: 500mg placebo (wheat flour) will be cnsumed before meals, three times per day.

Primary Outcome Measures :
  1. Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00970541

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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
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Principal Investigator: Leanne Redman, PhD Pennington Biomedical Research Center

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Responsible Party: Leanne Redman, Princiapal Investigator, Pennington Biomedical Research Center Identifier: NCT00970541     History of Changes
Other Study ID Numbers: PBRC 29010
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
low blood sugar
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs