Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

Insulin Resistance Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00970541
• Other study ID #: PBRC 29010
• Status: Terminated
• Phase: Phase 1
• Start date: August 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Cinnamon Supplementation
1, 3, or 6g of cinnamon per day for 40 days
• Placebo (wheat flour)
1, 3, or 6g of placebo per day for 40 days

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp		6 months