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

NCT05265715 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-01-08

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Lindsay Peterson, M.D., MSCR · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2024-03-22
Completion
2024-03-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05265715 on ClinicalTrials.gov