Improving Insulin Resistance in Gynecological Cancer Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Insulin Resistance
• Intervention / Treatment: Dietary supplement: Food plan with cinnamon supplementation; Behavioral: Food plan without cinnamon supplementation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Woman's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cinnamon with Food Plan; Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements.	Dietary supplement: Food plan with cinnamon supplementation; cinnamon twice daily plus follow Cardiometabolic diet; Other Names: Gaia Herbs Cinnamon Bark
ACTIVE_COMPARATOR: Food Plan Only; Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements.	Behavioral: Food plan without cinnamon supplementation; Cardiometabolic diet only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Woman's
• Collaborators: Woman's Hospital, Louisiana; Dietitians in Integrative and Functional Medicine DPG

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2020
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: RP-19-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No