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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04139694
Other study ID # RP-19-002
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 16, 2020
Est. completion date July 2020

Study information

Verified date May 2020
Source Woman's
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2020
Est. primary completion date May 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Food plan with cinnamon supplementation
cinnamon twice daily plus follow Cardiometabolic diet
Behavioral:
Food plan without cinnamon supplementation
Cardiometabolic diet only

Locations

Country Name City State
United States Woman's Hospital Baton Rouge Louisiana

Sponsors (3)

Lead Sponsor Collaborator
Woman's Dietitians in Integrative and Functional Medicine DPG, Woman's Hospital, Louisiana

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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