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

January 6, 2025 updated by: Washington University School of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low AGE dietary intervention
  • 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.
Other: Low AGE diet

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)
Procedure: Research blood draw
Baseline (Week 0), Week 4, Week 12, and Week 24 (end of intervention)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility as measured by adherence rate
Time Frame: At study completion for all enrolled participants (estimated to be 15 months)
  • 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%
At study completion for all enrolled participants (estimated to be 15 months)
Feasibility as measured by dropout rate
Time Frame: At study completion for all enrolled participants (estimated to be 15 months)
-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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in dietary AGE
Time Frame: At baseline and study completion (24 weeks)
-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.
At baseline and study completion (24 weeks)
Change in serum AGE
Time Frame: Baseline, week 12, and week 24
  • 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.
Baseline, week 12, and week 24
Correlation between serum AGE levels and BMI
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-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
Time Frame: Baseline, 12 weeks, and 24 weeks
-The relationship between dietary AGE and adiponectin will be assessed using rank based correlation.
Baseline, 12 weeks, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Cancer Society, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lindsay Peterson, M.D., MSCR, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202201100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article presentation.

IPD Sharing Access Criteria

Proposals should be directed to llpeterson@wustl.edu.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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