Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

Study Overview
=================
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.

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.

Conditions
-----------------
Polycystic Ovary Syndrome, Insulin Resistance

Intervention / Treatment
-----------------
* Dietary Supplement: Cinnamon Supplementation
* Dietary Supplement: Placebo (wheat flour)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cinnamon Supplementation<br>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<br>* 1, 3, or 6g of cinnamon per day for 40 days<br>* Other names: The bark of Cinnamoni Cassae;|
| Placebo Comparator: Placebo<br>A 500 mg placebo (wheat flour) will be consumed before meals, three times per day. | Dietary Supplement: Placebo (wheat flour)<br>* 1, 3, or 6g of placebo per day for 40 days<br>* Other names: 500mg placebo (wheat flour) will be cnsumed before meals, three times per day.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cinnamon, PCOS, low blood sugar, Insulin, Glucose