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

The Washington University

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Research blood draw; Other: Low AGE diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05265715

202201100

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Low AGE dietary intervention

Experimental group

Description:

* 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.

Treatment:

Other: Low AGE diet

Procedure: Research blood draw