Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00970541
First received: August 31, 2009
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
Insulin Resistance
Dietary Supplement: Cinnamon Supplementation
Dietary Supplement: Placebo (wheat flour)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970541

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

No publications provided

Responsible Party: Leanne Redman, Princiapal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00970541     History of Changes
Other Study ID Numbers: Eccentric
Study First Received: August 31, 2009
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Cinnamon
PCOS
low blood sugar
Insulin
Glucose

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014