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Improving Insulin Resistance in Gynecological Cancer Patients

Primary Purpose

Insulin Resistance

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food plan with cinnamon supplementation
Food plan without cinnamon supplementation
Sponsored by
Woman's
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Woman's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cinnamon with Food Plan

Food Plan Only

Arm Description

Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements.

Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 10, 2019
Last Updated
May 14, 2020
Sponsor
Woman's
Collaborators
Woman's Hospital, Louisiana, Dietitians in Integrative and Functional Medicine DPG
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1. Study Identification

Unique Protocol Identification Number
NCT04139694
Brief Title
Improving Insulin Resistance in Gynecological Cancer Patients
Official Title
Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
unable to procure supplement for clinical trial use
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's
Collaborators
Woman's Hospital, Louisiana, Dietitians in Integrative and Functional Medicine DPG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cinnamon with Food Plan
Arm Type
Experimental
Arm Description
Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements.
Arm Title
Food Plan Only
Arm Type
Active Comparator
Arm Description
Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements.
Intervention Type
Dietary Supplement
Intervention Name(s)
Food plan with cinnamon supplementation
Other Intervention Name(s)
Gaia Herbs Cinnamon Bark
Intervention Description
cinnamon twice daily plus follow Cardiometabolic diet
Intervention Type
Behavioral
Intervention Name(s)
Food plan without cinnamon supplementation
Intervention Description
Cardiometabolic diet only
Primary Outcome Measure Information:
Title
Improvement in mean glucose concentration
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
body mass index (BMI)
Description
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.
Time Frame
24 weeks
Title
body composition
Description
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.
Time Frame
24 weeks
Title
glucose tolerance
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Improving Insulin Resistance in Gynecological Cancer Patients

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