Clinical Trials Directory

Trials / Completed

CompletedNCT05265715

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
OTHERLow 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)
PROCEDUREResearch blood drawBaseline (Week 0), Week 4, Week 12, and Week 24 (end of intervention)

Timeline

Start date
2022-10-14
Primary completion
2024-03-22
Completion
2024-03-22
First posted
2022-03-03
Last updated
2025-01-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05265715. Inclusion in this directory is not an endorsement.