Improving Insulin Resistance in Gynecological Cancer Patients

Study Overview
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Brief Summary
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This is a research study to see if the addition of cinnamon to a provided food plan would improve insulin resistance in gynecological cancer patients. One study suggests that patients with gynecological cancers are more likely to be insulin resistant and/or have higher levels of fasting insulin. The study will be 24 weeks in length.

Official Title
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Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation

Conditions
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Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Food plan with cinnamon supplementation
* Behavioral: Food plan without cinnamon supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: previously diagnosed with gynecological cancer and has completed all surgical intervention, chemotherapy, and/or radiation at least 3 months prior to enrollment but not greater than 24 months post-menopausal BMI > 25 but < 40 Exclusion Criteria: no previous diagnosis of diabetes no other cancer diagnosis (excluding skin) no chronic use of medication(s) interfering with glucose metabolism
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinnamon with Food Plan<br>Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements. | Dietary Supplement: Food plan with cinnamon supplementation<br>* cinnamon twice daily plus follow Cardiometabolic diet<br>* Other names: Gaia Herbs Cinnamon Bark;|
| Active Comparator: Food Plan Only<br>Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements. | Behavioral: Food plan without cinnamon supplementation<br>* Cardiometabolic diet only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in mean glucose concentration | To determine whether the addition of cinnamon to the implementation of an integrative and functional (IF) food plan will show a difference of 10 mg% in the mean glucose concentration measured when comparing the baseline and 24 week Oral Glucose Tolerance Test (OGTT) glucose levels. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index (BMI) | To determine whether the addition of cinnamon to the implementation of an IF food plan will improve BMI more than just dietary intervention alone. BMI will be calculated by dividing the participant's weight by her height squared. | 24 weeks | 
| body composition | To determine whether the addition of cinnamon to the implementation of an IF food plan will improve the ratio of fat mass to fat free mass more than just dietary intervention alone. We will measure using a Fit3D scanner that uses infrared cameras to estimate fat mass and fat free mass. | 24 weeks | 
| glucose tolerance | To determine whether the addition of cinnamon to the implementation of an IF food plan will improve glucose tolerance levels more than just dietary intervention alone. It will be measured using the results of the baseline and final 2-hour Oral Glucose Tolerance Test which measures glucose and insulin at 4 time points. | 24 weeks |