Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation
Phase: NA
Conditions: Insulin Resistance
Sponsor: Woman's

 
 
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Improving insulin resistance in gynecological cancer patients post-treatment using an integrative 
and functional medicine (IFM) food plan with and without cinnamon supplementation 
10/07/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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STUDY PROTOCOL 
Improving insulin resistance in gynecological cancer patients post-treatment using an integrative 
and functional medicine (IFM) food plan with and without cinnamon supplementation 
Principal Investigator:  
Brooke Schoonenberg,   
 
 
 
 
 
 
 
 
       
9637 Jefferson Hwy.                                                                                                                                                                   
Baton Rouge, LA  70809                                                                                                                                                          
225-924-8936 
 
Co-Investigators: 
Tammy Dupuy, MD, IFM-Certified Practitioner                                                                                                                        
500 Rue de la Vie, Suite # 410                                                                                                                                                    
Baton Rouge, LA  70817                                                                                                                                                             
225-216-3006 
 
Karen Elkind-Hirsch, Ph.D.                                                                                                                                                        
500 Rue de la Vie, Ste. 513                                                                                                                                                         
Baton Rouge, LA  70817                                                                                                                                                             
225-924-5278 
 
Beverly Ogden, MD                                                                                                                                                                    
100 Woman’s Way                                                                                                                                                                      
Baton Rouge, LA  70817                                                                                                                                                             
225-924-8279 
 
Purpose of Study 
The purpose of the study is to determine if the addition of cinnamon to a dietary intervention using an 
IFM food plan will be more effective in improving insulin resistance in post treatment gynecological 
cancer patients than using the food plan alone.  The study results will be submitted to Dietitians in 
Integrative and Functional Medicine as an article in the newsletter and/or presented as a poster at the 
national conference.  We intend to follow these patients long-term to determine if the food plan and any 
change in insulin sensitivity effects cancer recurrence. 
Study Rational   
Studies have shown that the supplementation with cinnamon in patients with type II diabetes and in 
patients with insulin resistance associated with polycystic ovarian syndrome can result in decreased mean 
fasting glucose, total available glucose, insulin levels, cholesterol levels and Hb A1c.  Improvements were 
also noted in percentage body fat. Response rates were related to duration of the study, and the extent of 
obesity and glucose intolerance of the patient. The patients had to take the supplements for at least 24 
weeks to see an effect.   

 
 
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Study Design 
Participants will submit for the following blood draw tests:  Oral Glucose Tolerance Test (OGTT) with 
insulins at baseline and week twenty-four.  Participants in the supplement group will begin taking a 
supplement of cinnamon (cinnamon bark, 1700 mg/day) at week one and throughout the twenty-four 
weeks.  Participants in the control group will take no supplement.  All participants will begin the 
Integrative and Functional Medicine Cardiometabolic Food Plan (uses a modified Mediterranean 
approach with low glycemic impact) at week one and throughout the twenty-four weeks.  Participants will 
meet with a registered dietitian during week one and fourteen for support with the food plan.  Participants 
will self-monitor intake of food and nutrients, and complete weekly food logs for the dietitian to review. 
The results of the lab tests will be collected as pre and post study data.  Evaluation will include the 
following calculations derived from the OGTT: Insulin sensitivity index, HOMA-IR, Matsuda index, 
corrected early insulin secretory response (insulinogenic index/HOMA-IR and oral disposition index 
(product of Matsuda index and insulinogenic index. A mean glucose concentration will be calculated by 
looking at the serum values at 0 minutes, 30 minutes, 60 minutes and 120 minutes divided by 4. The 
mean glucose concentrations will be compared pre and post study in each arm and the pre and post study 
comparing arms. Liver enzymes will be checked on all participants eight weeks after starting the protocol 
and through cancer surveillance follow up.  The following additional measurements will be taken at 
baseline and at 24 weeks: 
Body fat determination using the Fit3D body scanner which is a noninvasive body scanner used to take 
measurements and a 3-dimensional view of the body, BMI calculation, and waist-hip ratio. 
 
Study Objectives 
Primary: To determine whether the addition of cinnamon to the implementation of an IF food plan will 
show a difference of 10 mg% in the mean glucose concentration measured when comparing the baseline 
and 24 week OGTT glucose levels. 
 Secondary: To determine whether the addition of cinnamon to the implementation of an IF food plan will 
improve weight loss, BMI, waist-hip ratio and glucose tolerance  levels and related calculations more than  
just dietary intervention alone. 
The Woman’s Hospital departments involved in the study include Gynecological Oncology to identify 
study participants, Health Information Management, Laboratory, Pharmacy for distribution of cinnamon 
supplements, and nutrition services Study Plan and Procedures. 
Week 0 
Labs, body fat 
composition, BMI 
calculation, waist-hip ratio 
measurements
Week 1 Dietitian 
education with food plan, 
instruction about food and 
exercise 
logs,randomization
Week 14
Dietitian education, review 
of food and exercise logs
Week  24 repeat Labs ,  
body fat composition 
assessment, BMI 
calculation, waist-hip ratio 
measurements, review of 
food and exercise logs

 
 
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Design   
Prospective, randomized outpatient efficacy trial 
Study Inclusion/Exclusion 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 (absence of menstruation for > 1 year) 
BMI > 25 but < 40   
Exclusion Criteria: 
No previous diagnosis of diabetes (HbA1c > 6.5%) 
No other cancer diagnosis, excluding skin cancer  
No chronic use of medication(s) interfering with glucose metabolism i.e. steroids, etc.  
Consent of Subjects 
Participation in the study is voluntary and participants may withdraw at any time by contacting the 
principal investigator. Signed consent gives Woman’s Hospital the right to keep data for the time that the 
participant is being surveyed by Woman’s gynecological oncology physicians.  De-identified data may be 
used in publication. 
Risk/Benefit to Study Participants 
Allergic reaction to the cinnamon supplement may occur.  Common symptoms of an allergic reaction 
include: nausea, stomach pain, diarrhea, vomiting, tingling/itching/swelling of face or other parts of the 
body, difficulty breathing, hives, dizziness, fainting, and rashes/inflammation/irritation or blistering of the 
skin. 
Anaphylaxis is rare but can be potentially fatal and needs urgent medical attention.  Symptoms include:  
sudden drop in blood pressure, difficulty breathing, loss of consciousness, and shock. 
Blood draws may cause fainting, dizziness, and pain at injection site.   
We anticipate that those who follow the food plan will lose an average of 5% of their body weight, and 
will improve their insulin sensitivity.  We hope this food plan will decrease the risk of cancer recurrence.  
We hope this study will help cancer patients in the future.  We will enroll 40 participants into this study. 
 

 
 
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Explanation of Statistics and Data Analysis 
Sample size calculation was performed using the online calculator provided by the Massachusetts General 
Hospital Mallinckrodt General Clinical Research Center using a change of 10mg% n the mean glucose 
concentration as an endpoint. The sample size required would be 40 subjects, 20 in each arm. 
Any statistics and data will be de-identified prior to presenting or publishing.  Data will be kept within 
Woman’s Hospital for any patient being monitored by Woman’s Gynecological Oncology team.   
How Records/Data will be Kept Confidential  
Records and data from this study may include paper records that will be stored in a locked filing cabinet 
during the initial 6 months of the study and will be scanned into an electronic record and stored in a 
password protected electronic file thereafter as the patients are followed long-term by the gynecological 
oncology team. The participant’s study records will be a part of their medical chart. 
 
References: 
 Wambago et al. Do Cinnamon Supplements Have a Role in Glycemic Control in Type II Diabetes? A 
Narrative Review. J Acad Nutr Diet. 2016 Nov;116 (11): 1794-1802 
Anderson RA. Chromium and polyphenols from cinnamon improve insulin sensitivity. Proc Nutr Soc. 
2008 Feb; 67 (1): 48-53 
Association of insulin resistance with breast, ovarian, endometrial and cervical cancers in non-diabetic 
women   Am J Cancer Res. 2016; 6(10): 2334–2344.