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
| Type | Name | Description |
|---|---|---|
| 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) |
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.