Insulin Resistance
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTFood plan with cinnamon supplementation
cinnamon twice daily plus follow Cardiometabolic diet
BEHAVIORALFood plan without cinnamon supplementation
Cardiometabolic diet only
Sponsors
Woman's Hospital, Louisiana
Dietitians in Integrative and Functional Medicine DPG
Woman's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in mean glucose concentration | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body mass index (BMI) | 24 weeks | 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. |
| body composition | 24 weeks | 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. |
| glucose tolerance | 24 weeks | 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. |
Countries
United States
Outcome results
None listed