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Improving Insulin Resistance in Gynecological Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04139694
Recruitment Status : Withdrawn (unable to procure supplement for clinical trial use)
First Posted : October 25, 2019
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
Woman's Hospital, Louisiana
Dietitians in Integrative and Functional Medicine DPG
Information provided by (Responsible Party):
Brooke Schoonenberg, Woman's

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Dietary Supplement: Food plan with cinnamon supplementation Behavioral: Food plan without cinnamon supplementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

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 Name: 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




Primary Outcome Measures :
  1. Improvement in mean glucose concentration [ Time Frame: 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 Outcome Measures :
  1. body mass index (BMI) [ Time Frame: 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.

  2. body composition [ Time Frame: 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.

  3. glucose tolerance [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139694


Locations
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United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70809
Sponsors and Collaborators
Woman's
Woman's Hospital, Louisiana
Dietitians in Integrative and Functional Medicine DPG
  Study Documents (Full-Text)

Documents provided by Brooke Schoonenberg, Woman's:
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Responsible Party: Brooke Schoonenberg, Nutrition Services Manager, Woman's
ClinicalTrials.gov Identifier: NCT04139694    
Other Study ID Numbers: RP-19-002
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases