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Completed

NCT Number: NCT05265715

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low AGE Diet

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

Procedure

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

Primary outcomes

  1. Feasibility as measured by adherence rate

    Time frame: At study completion for all enrolled participants (estimated to be 15 months)

    • Feasibility is a defined adherence rate of at least 80% of participants enrolled
    • Diet adherence will be categorized by the study dietitian at the end of the study and before the results of AGEs in serum or any analysis of outcomes to avoid bias. Following each phone session with the participants, the dietitian will elicit answers to the following question: since the last call did the participant use any cooking methods they were advised to avoid for certain food items? (yes/no).
    • The information will be used to calculate an adherence score. Adherence score is % phone calls of patient's report for full maintaining instructions to reduce AGEs.
    • Very high adherence= ≥80%; good adherence= 60-80%; partial adherence= 40-60%; lack of adherence but intention to adhere more in the future= ≤40%; lack of adherence and no intention to adhere more= ≤40%

  2. Feasibility as measured by dropout rate

    Time frame: At study completion for all enrolled participants (estimated to be 15 months)

    -Feasibility is defined as a dropout rate of less than 20% of participants enrolled

Secondary outcomes

  1. Change in dietary AGE

    Time frame: At baseline and study completion (24 weeks)

    -Dietary AGE is estimated based on analysis of the 3 day food record patients will complete at baseline and study completion. A specific dietary AGE value will be assigned to each item on the 3 day food recall by consultant and dietary AGE expert Jaime Uribarri, MD. This value is based on his published dietary AGE database which accounts for type of food, portion size and cooking methods.

  2. Change in serum AGE

    Time frame: Baseline, week 12, and week 24

    • Blood specimens for serum AGE analysis will be shipped from the University of San Diego Biorepository to the Medical University of South Carolina to be analyzed in the lab of study team member and expert AGE analyst, Dr. David Turner.
    • AGE (measured by the AGE metabolite carboxymethyllysine (ug/ml)) will be assessed in serum using commercially available 96-well format ELISA's and ROS detection kits (Cell Biolabs). Nε-carboxymethyllysine (CML) is an AGE metabolite extensively studied in animal models of disease and with regard to food content.

  3. Correlation between serum AGE levels and BMI

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between serum AGE levels and BMI will be assessed using rank based correlation.

  4. Correlation between serum AGE levels and serum CRP

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between serum AGE levels and serum CRP will be assessed using rank based correlation.

  5. Correlation between serum AGE levels and IL6

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between serum AGE levels and IL6 will be assessed using rank based correlation.

  6. Correlation between serum AGE levels and glucose

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between serum AGE levels and glucose will be assessed using rank based correlation.

  7. Correlation between serum AGE levels and leptin

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between serum AGE levels and leptin will be assessed using rank based correlation.

  8. Correlation between serum AGE levels and adiponectin

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between serum AGE levels and adiponectin will be assessed using rank based correlation.

  9. Correlation between dietary AGE and BMI

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between dietary AGE and BMI will be assessed using rank based correlation.

  10. Correlation between dietary AGE and serum CRP

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between dietary AGE and serum CRP will be assessed using rank based correlation.

  11. Correlation between dietary AGE and IL6

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between dietary AGE and IL6 will be assessed using rank based correlation.

  12. Correlation between dietary AGE and insulin

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between dietary AGE and insulin will be assessed using rank based correlation.

  13. Correlation between dietary AGE and glucose

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between dietary AGE and glucose will be assessed using rank based correlation.

  14. Correlation between dietary AGE and leptin

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between dietary AGE and leptin will be assessed using rank based correlation.

  15. Correlation between dietary AGE and adiponectin

    Time frame: Baseline, 12 weeks, and 24 weeks

    -The relationship between dietary AGE and adiponectin will be assessed using rank based correlation.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2022
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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