Breast CancerNCT05265715

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

A study testing Low AGE diet and Research blood draw in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Low AGE diet and Research blood draw
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 14 Oct 2022to 22 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

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About this study

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.

Conditions: Breast Cancer
Being tested: Low AGE diet, Research blood draw
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low AGE dietOther
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)
Research blood drawProcedure or surgery
Baseline (Week 0), Week 4, Week 12, and Week 24 (end of intervention)

Study groups in NCT05265715
Study group	Role	What they receive
Low AGE dietary intervention	Experimental	* 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. Receives: Other: Low AGE diet; Procedure: Research blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (15)

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.
Measured: At baseline and study completion (24 weeks)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 202222 Mar 2024

First posted3 Mar 2022
Study start14 Oct 2022
Primary completion22 Mar 2024
Study completion22 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05265715
Sponsor's protocol ID: 202201100
Status last verified: Jan 2025
First submitted: 31 Jan 2022
Last updated: 8 Jan 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors
ClinicalTrials.gov ID: NCT05265715
Acronym / sponsor ID: 202201100
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: American Cancer Society, Inc.
Study start: 14 Oct 2022 (actual)
Primary completion: 22 Mar 2024 (actual)
Study completion: 22 Mar 2024 (actual)
First posted: 3 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Low AGE dietary intervention	Experimental	Other: Low AGE diet, Procedure: Research blood draw* 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low AGE dietThe 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)	Other	Low AGE dietary intervention
Research blood drawBaseline (Week 0), Week 4, Week 12, and Week 24 (end of intervention)	Procedure or surgery	Low AGE dietary intervention

Primary outcome

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%
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

15 secondary outcomes

Change in dietary AGE
Time frame: At baseline and study completion (24 weeks)
Change in serum AGE
Time frame: Baseline, week 12, and week 24
Correlation between serum AGE levels and BMI
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between serum AGE levels and serum CRP
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between serum AGE levels and IL6
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between serum AGE levels and glucose
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between serum AGE levels and leptin
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between serum AGE levels and adiponectin
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between dietary AGE and BMI
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between dietary AGE and serum CRP
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between dietary AGE and IL6
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between dietary AGE and insulin
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between dietary AGE and glucose
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between dietary AGE and leptin
Time frame: Baseline, 12 weeks, and 24 weeks
Correlation between dietary AGE and adiponectin
Time frame: Baseline, 12 weeks, and 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lindsay Peterson, M.D., MSCR principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low AGE diet and Research blood draw in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility as measured by adherence rate (time frame: At study completion for all enrolled participants (estimated to be 15 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05265715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.