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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The scientific premise for this study is the known impact of overweight/obesity on breast cancer risk and outcomes, the association between advanced glycation end-products (AGE) and high fat, highly processed foods common in Western diets, and the preclinical evidence suggesting a link between AGE and breast cancer independent of weight. The association between dietary and serum AGE in breast cancer survivors and prognosis has not been previously evaluated. However, preclinical studies suggest that AGE may represent a novel, lifestyle-linked, modifiable, prognostic biomarker, which could be targeted through lifestyle (diet and exercise) and/or pharmaceutical interventions to improve breast cancer prognosis. The proposed study will pave the way for a large scale randomized controlled trial to evaluate the impact of a low AGE diet on weight (BMI), known (IL-6 and CRP) and novel (AGE and RAGE) prognostic biomarkers, and ultimately on breast cancer prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low AGE dietary intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low AGE diet | Other | The recommended daily AGE intake will be either:
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as measured by adherence rate |
| At study completion for all enrolled participants (estimated to be 15 months) |
| Feasibility as measured by dropout rate | -Feasibility is defined as a dropout rate of less than 20% of participants enrolled | At study completion for all enrolled participants (estimated to be 15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dietary AGE | -Dietary AGE is estimated based on analysis of the 3 day food record patients will complete at baseline and study completion. A specific dietary AGE value will be assigned to each item on the 3 day food recall by consultant and dietary AGE expert Jaime Uribarri, MD. This value is based on his published dietary AGE database which accounts for type of food, portion size and cooking methods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay Peterson, M.D., MSCR | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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All research data will be shared between Dr. Peterson and the study team will be available to all investigators named on this proposal. The primary investigators are also willing to share data and materials with other eligible investigators and collaborators through academically established means. Final data will be shared in an openly and timely manner while ensuring the privacy and confidentiality of participants through presentations at scientific seminars and conference and publications in peer reviewed journals. Information about the intervention protocol and survey tools will be made available to others upon request.
Beginning 3 months and ending 5 years following article presentation.
Proposals should be directed to llpeterson@wustl.edu.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Research blood draw | Procedure | Baseline (Week 0), Week 4, Week 12, and Week 24 (end of intervention) |
|
| At baseline and study completion (24 weeks) |
| Change in serum AGE |
| Baseline, week 12, and week 24 |
| Correlation between serum AGE levels and BMI | -The relationship between serum AGE levels and BMI will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between serum AGE levels and serum CRP | -The relationship between serum AGE levels and serum CRP will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between serum AGE levels and IL6 | -The relationship between serum AGE levels and IL6 will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between serum AGE levels and glucose | -The relationship between serum AGE levels and glucose will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between serum AGE levels and leptin | -The relationship between serum AGE levels and leptin will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between serum AGE levels and adiponectin | -The relationship between serum AGE levels and adiponectin will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between dietary AGE and BMI | -The relationship between dietary AGE and BMI will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between dietary AGE and serum CRP | -The relationship between dietary AGE and serum CRP will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between dietary AGE and IL6 | -The relationship between dietary AGE and IL6 will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between dietary AGE and insulin | -The relationship between dietary AGE and insulin will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between dietary AGE and glucose | -The relationship between dietary AGE and glucose will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between dietary AGE and leptin | -The relationship between dietary AGE and leptin will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| Correlation between dietary AGE and adiponectin | -The relationship between dietary AGE and adiponectin will be assessed using rank based correlation. | Baseline, 12 weeks, and 24 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |