A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low AGE diet

Research blood draw

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of breast cancer, any subtype, stage I-III, within the last 36 months, who have completed primary therapy of their breast cancer (surgery, radiation, and chemotherapy). Must be at least 4 weeks post their last chemotherapy or radiation therapy. Concurrent hormonal therapy is allowed.
At least 18 years of age.
Determined to have a high AGE diet at baseline (dietary AGE intake greater than 14 Eq/day as assessed by food frequency questionnaire).
Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

Diagnosis of diabetes.
History of eating disorder or body dysmorphic disorder.
Active tobacco use (tobacco is a source of advanced glycation end products).
Active participation in other dietary or physical activity clinical trials or community interventions.
Taking and unwilling/unable to stop taking B-6 (pyridoxamine), B1 (thiamine) or metformin (all known AGE inhibitors).

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low AGE dietary intervention

Arm Description

Patients will complete a food frequency questionnaire, & if found to have a high AGE diet at baseline, will then begin the study the 24-week low AGE dietary intervention. Patients will complete a 3 day food record prior to receiving remotely delivered education on AGEs on how to adhere to a low AGE diet by the study dieticians prior to starting. This session will provide education on dietary AGE & how to prepare & choose low AGE meals Subsequent sessions with the dieticians will be conducted remotely & will be 30-60 minutes in duration, with the exception of sessions scheduled for weeks when a study blood draw is required, when visits with the dietician may occur in person. These sessions will occur at the following schedule: weekly during the first 2 months (8 sessions), every other week during the next 2 months (4 sessions, aka step down sessions), monthly for the remaining 2 months (2 sessions) 3 day food records will be collected at 12 & 24 weeks, in addition to baseline.

Outcomes

Primary Outcome Measures

Feasibility as measured by adherence rate

Feasibility is a defined adherence rate of at least 80% of participants enrolled Diet adherence will be categorized by the study dietitian at the end of the study and before the results of AGEs in serum or any analysis of outcomes to avoid bias. Following each phone session with the participants, the dietitian will elicit answers to the following question: since the last call did the participant use any cooking methods they were advised to avoid for certain food items? (yes/no). The information will be used to calculate an adherence score. Adherence score is % phone calls of patient's report for full maintaining instructions to reduce AGEs. Very high adherence= ≥80%; good adherence= 60-80%; partial adherence= 40-60%; lack of adherence but intention to adhere more in the future= ≤40%; lack of adherence and no intention to adhere more= ≤40%

Feasibility as measured by dropout rate

-Feasibility is defined as a dropout rate of less than 20% of participants enrolled

Secondary Outcome Measures

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.

Change in serum AGE

Blood specimens for serum AGE analysis will be shipped from the University of San Diego Biorepository to the Medical University of South Carolina to be analyzed in the lab of study team member and expert AGE analyst, Dr. David Turner. AGE (measured by the AGE metabolite carboxymethyllysine (ug/ml)) will be assessed in serum using commercially available 96-well format ELISA's and ROS detection kits (Cell Biolabs). Nε-carboxymethyllysine (CML) is an AGE metabolite extensively studied in animal models of disease and with regard to food content.

Correlation between serum AGE levels and BMI

-The relationship between serum AGE levels and BMI will be assessed using rank based correlation.

Correlation between serum AGE levels and serum CRP

-The relationship between serum AGE levels and serum CRP will be assessed using rank based correlation.

Correlation between serum AGE levels and IL6

-The relationship between serum AGE levels and IL6 will be assessed using rank based correlation.

Correlation between serum AGE levels and glucose

-The relationship between serum AGE levels and glucose will be assessed using rank based correlation.

Correlation between serum AGE levels and leptin

-The relationship between serum AGE levels and leptin will be assessed using rank based correlation.

Correlation between serum AGE levels and adiponectin

-The relationship between serum AGE levels and adiponectin will be assessed using rank based correlation.

Correlation between dietary AGE and BMI

-The relationship between dietary AGE and BMI will be assessed using rank based correlation.

Correlation between dietary AGE and serum CRP

-The relationship between dietary AGE and serum CRP will be assessed using rank based correlation.

Correlation between dietary AGE and IL6

-The relationship between dietary AGE and IL6 will be assessed using rank based correlation.

Correlation between dietary AGE and insulin

-The relationship between dietary AGE and insulin will be assessed using rank based correlation.

Correlation between dietary AGE and glucose

-The relationship between dietary AGE and glucose will be assessed using rank based correlation.

Correlation between dietary AGE and leptin

-The relationship between dietary AGE and leptin will be assessed using rank based correlation.

Correlation between dietary AGE and adiponectin

-The relationship between dietary AGE and adiponectin will be assessed using rank based correlation.

Full Information

NCT ID

NCT05265715

First Posted

January 31, 2022

Last Updated

April 20, 2023

Sponsor

Washington University School of Medicine

Collaborators

American Cancer Society, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05265715

Brief Title

A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors

Official Title

A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 14, 2022 (Actual)

Primary Completion Date

December 10, 2023 (Anticipated)

Study Completion Date

December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

American Cancer Society, Inc.

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

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.

6. Conditions and Keywords

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

Breast Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low AGE dietary intervention

Arm Type

Experimental

Arm Description

Patients will complete a food frequency questionnaire, & if found to have a high AGE diet at baseline, will then begin the study the 24-week low AGE dietary intervention. Patients will complete a 3 day food record prior to receiving remotely delivered education on AGEs on how to adhere to a low AGE diet by the study dieticians prior to starting. This session will provide education on dietary AGE & how to prepare & choose low AGE meals Subsequent sessions with the dieticians will be conducted remotely & will be 30-60 minutes in duration, with the exception of sessions scheduled for weeks when a study blood draw is required, when visits with the dietician may occur in person. These sessions will occur at the following schedule: weekly during the first 2 months (8 sessions), every other week during the next 2 months (4 sessions, aka step down sessions), monthly for the remaining 2 months (2 sessions) 3 day food records will be collected at 12 & 24 weeks, in addition to baseline.

Intervention Type

Other

Intervention Name(s)

Low AGE diet

Intervention Description

The recommended daily AGE intake will be either: 7,500 kilounits [ku], which is a 50% reduction from the average 15,000 ku consumed by most adults or a 50% reduction from their baseline AGE intake (based on 3-day food AGE record)

Intervention Type

Procedure

Intervention Name(s)

Research blood draw

Intervention Description

Baseline (Week 0), Week 4, Week 12, and Week 24 (end of intervention)

Primary Outcome Measure Information:

Title

Feasibility as measured by adherence rate

Description

Feasibility is a defined adherence rate of at least 80% of participants enrolled Diet adherence will be categorized by the study dietitian at the end of the study and before the results of AGEs in serum or any analysis of outcomes to avoid bias. Following each phone session with the participants, the dietitian will elicit answers to the following question: since the last call did the participant use any cooking methods they were advised to avoid for certain food items? (yes/no). The information will be used to calculate an adherence score. Adherence score is % phone calls of patient's report for full maintaining instructions to reduce AGEs. Very high adherence= ≥80%; good adherence= 60-80%; partial adherence= 40-60%; lack of adherence but intention to adhere more in the future= ≤40%; lack of adherence and no intention to adhere more= ≤40%

Time Frame

At study completion for all enrolled participants (estimated to be 15 months)

Title

Feasibility as measured by dropout rate

Description

-Feasibility is defined as a dropout rate of less than 20% of participants enrolled

Time Frame

At study completion for all enrolled participants (estimated to be 15 months)

Secondary Outcome Measure Information:

Title

Change in dietary AGE

Description

-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.

Time Frame

At baseline and study completion (24 weeks)

Title

Change in serum AGE

Description

Blood specimens for serum AGE analysis will be shipped from the University of San Diego Biorepository to the Medical University of South Carolina to be analyzed in the lab of study team member and expert AGE analyst, Dr. David Turner. AGE (measured by the AGE metabolite carboxymethyllysine (ug/ml)) will be assessed in serum using commercially available 96-well format ELISA's and ROS detection kits (Cell Biolabs). Nε-carboxymethyllysine (CML) is an AGE metabolite extensively studied in animal models of disease and with regard to food content.

Time Frame

Baseline, week 12, and week 24

Title

Correlation between serum AGE levels and BMI

Description

-The relationship between serum AGE levels and BMI will be assessed using rank based correlation.

Time Frame