Clinical trial NCT00970541: Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome
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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Keywords: Cinnamon
PCOS
low blood sugar
Insulin
Glucose
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 8
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne Redman, PhD
role: PRINCIPAL_INVESTIGATOR
References: