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

NCT ID: NCT05265715

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2024-03-22

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low AGE diet

Intervention Type: OTHER

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 draw

Intervention Type: PROCEDURE

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

Interventions

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)

Intervention Type: OTHER

Research blood draw

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Peterson, M.D., MSCR

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

202201100

Identifier Type: -

Identifier Source: org_study_id