Effect of Daily Avocado Consumption on Cellular Aging in Female Breast Cancer Survivors: The ACCA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline in leukocyte telomere length
研究概览
简要总结
Women with breast cancer are at increased risk of comorbidities and premature mortality, potentially due to accelerated biological aging. Telomere attrition has been proposed as a biomarker of this process, which could be mitigated through interventions targeting behavioral factors such as diet. In recent years, avocado has drawn attention in nutritional research due to its unique nutritional profile.
Main objective: To evaluate the effect of consuming one avocado per day on biological aging-measured by telomere length-in breast cancer survivors, compared to a habitual diet (less than two avocados per week). Secondary objectives include changes in telomerase activity and biomarkers of inflammation and oxidative stress. Additional objectives include classical cardiovascular disease markers (glucose metabolism, lipid profile, blood pressure); anthropometric measurements; symptoms of depression and anxiety; quality of life and fatigue; and diet quality.
Methodology: A randomized controlled parallel-group trial involving 120 breast cancer survivors. Participants will be randomly assigned to either the intervention group (one avocado per day) or the control group (habitual diet with fewer than two avocados per week) and followed for 4 months. At baseline and the end of the intervention, a general questionnaire will be administered; blood and urine samples will be collected; anthropometric and blood pressure measurements will be taken; and diet, physical activity, symptoms of depression and anxiety, quality of life, and fatigue will be assessed. Mean changes from baseline to the end of the intervention in the primary outcome (telomere length) and secondary outcomes (inflammation, oxidative stress, classical cardiovascular disease markers, anthropometric measures, symptoms of depression and anxiety, quality of life, and diet) will be compared between the intervention and control groups using linear regression models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with primary breast cancer in stages I, II or III;
- •40-65 years old at screening;
- •Cancer treatment (radiotherapy and chemotherapy) completed ≥ 6 months but not more than 10 years at the time of recruitment;
- •Currently consuming less than 2 avocados per week;
- •Signed the informed consent letter.
排除标准
- •Metastasis;
- •Ductal carcinoma or lobular carcinoma in situ;
- •Breast cancer recurrence;
- •Cancer diagnosis other than breast cancer or non-melanoma skin cancer;
- •Body mass index ≥40kg/m2;
- •Currently pregnant or breastfeeding, or planning pregnancy in the following 6 months;
- •Allergy to latex;
- •Unwilling to consume avocado;
- •Immunodeficiency or HIV-positive status;
- •Alcohol abuse (>50g/day);
- •Unstable use of plant sterols, mineral supplements, use of fibre supplements, fish oil, or antioxidants in the 4 weeks prior to enrolment, or plans to change this during the study;
- •Currently participating in any other randomized controlled trial;
- •Difficulty or impossibility of an adequate follow-up;
- •Inability or unwillingness to give written informed consent or to communicate with study personnel, or illiteracy;
- •Patients with an acute infection or inflammation (e.g., pneumonia) will be allowed to participate in the study 3 months after recovery.
研究组 & 干预措施
Daily Avocado Consumption
Participants assigned to the intervention group will be advised to follow their usual diet and to consume one avocado per day for the next four months. To ensure and facilitate compliance with the intervention, we will provide a leaflet with some recipes for incorporating avocados into their regular diet.
Avocados will be provided for free. Participants will pick up avocados every two weeks from the study site.
干预措施: Daily Avocado Consumption (Other)
Control - Usual Diet
Participants allocated to the control group will be advised to follow their usual diet. Avocado consumption will not be encouraged.
结局指标
主要结局
Change from baseline in leukocyte telomere length
时间窗: Participants will be followed for 4 months. Measurements will be done before and after 4 months.
Telomere length (TL) analysis will be performed employing the traditional real-time PCR(1) method (Cawthon 2009) by the QuantiTect Syber Green PCR kit (Qiagen). This approach employs the 36B4R single-copy gene as a reference for each sample. The measurements will be performed on a monochrome multiplex real-time quantitative PCR in a BioradCFX96 thermocycler on samples collected before and after the intervention. The data obtained by PCR will be expressed as the ratio of telomere/reference gene (T / S) as the ratio between the number of copies of the telomeric repeat (T) and a single copy gene (36B4F) (S)
次要结局
- Change from baseline in telomerase activity(Participants will be followed for 4 months. Measurements will be done before and after 4 months.)
- Change from baseline in inflammatory markers(Participants will be followed for 4 months. Measurements will be done before and after 4 months.)
- Change from baseline in oxidative markers(Participants will be followed for 4 months. Measurements will be done before and after 4 months.)
研究者
Nerea Becerra Tomás
Principal Investigator
Institut Investigacio Sanitaria Pere Virgili