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unable to procure supplement for clinical trial use
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| Name | Class |
|---|---|
| Woman's Hospital, Louisiana | OTHER |
| Dietitians in Integrative and Functional Medicine DPG | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinnamon with Food Plan | Experimental | Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements. |
|
| Food Plan Only | Active Comparator | Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food plan with cinnamon supplementation | Dietary Supplement | cinnamon twice daily plus follow Cardiometabolic diet |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woman's Hospital | Baton Rouge | Louisiana | 70809 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2019 | Oct 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Food plan without cinnamon supplementation | Behavioral | Cardiometabolic diet only |
|
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 |