A Low AGE (Advanced Glycation End-product) Dietary Intervention for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Feasibility as measured by adherence rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Low AGE dietary intervention
- 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.
干预措施: Low AGE diet (Other)
Low AGE dietary intervention
- 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.
干预措施: Research blood draw (Procedure)
结局指标
主要结局
Feasibility as measured by adherence rate
时间窗: 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%
Feasibility as measured by dropout rate
时间窗: 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
次要结局
- Correlation between serum AGE levels and adiponectin(Baseline, 12 weeks, and 24 weeks)
- Correlation between dietary AGE and IL6(Baseline, 12 weeks, and 24 weeks)
- Correlation between serum AGE levels and leptin(Baseline, 12 weeks, and 24 weeks)
- Correlation between dietary AGE and serum CRP(Baseline, 12 weeks, and 24 weeks)
- Correlation between serum AGE levels and serum CRP(Baseline, 12 weeks, and 24 weeks)
- Correlation between dietary AGE and insulin(Baseline, 12 weeks, and 24 weeks)
- Correlation between dietary AGE and adiponectin(Baseline, 12 weeks, and 24 weeks)
- Change in dietary AGE(At baseline and study completion (24 weeks))
- Change in serum AGE(Baseline, week 12, and week 24)
- Correlation between serum AGE levels and BMI(Baseline, 12 weeks, and 24 weeks)
- Correlation between serum AGE levels and IL6(Baseline, 12 weeks, and 24 weeks)
- Correlation between serum AGE levels and glucose(Baseline, 12 weeks, and 24 weeks)
- Correlation between dietary AGE and BMI(Baseline, 12 weeks, and 24 weeks)
- Correlation between dietary AGE and glucose(Baseline, 12 weeks, and 24 weeks)
- Correlation between dietary AGE and leptin(Baseline, 12 weeks, and 24 weeks)