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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Avocado Consumption | Experimental | 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. |
|
| Control - Usual Diet | No Intervention | Participants allocated to the control group will be advised to follow their usual diet. Avocado consumption will not be encouraged. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Avocado Consumption | Other | Participants follow their usual diet and consume one avocado per day for 4 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in leukocyte telomere length | 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) | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in telomerase activity | Telomerase activity will be assessed in white blood cells (PBMCs) using the TeloTAGGG Telomerase PCR ELISAPLUS method, a photometric enzyme immunoassay for quantitative determination of telomerase activity, utilizing the Telomeric Repeat Amplification Protocol (TRAP) (Sigma Aldrich). | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting glucose | Fasting glucose in mg/dL will be measured by standardized methods | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in glycated hemoglobin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nerea Becerra Tomás, PhD | Contact | +34977759334 | nerea.becerra@urv.cat | |
| Victoria Arija, Professor | Contact | +34977759334 | victoria.arija@urv.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit for Public Health and Nutritional Epidemiology, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili | Recruiting | Reus | Tarragona | 43201 | Spain |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Change from baseline in inflammatory markers | Blood samples will be collected in the morning after 8-12h fast. Inflammatory markers (C-reactive protein, IL-1β, IL-6, TNFα, IL-8, IL-10) will be measured by commercial ELISA. | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in oxidative markers | Blood samples will be collected in the morning after an 8-12h fast. Oxidized LDL will be measured in plasma. Spot urine will be collected, and 8-iso-prostaglandin F2α (8-isoprostanes) will be measured. | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
glycated hemoglobin (HbA1c) in % will be measured by standardized methods
| Participants will be followed for 4 months. Measurements will be done before and after 4 months |
| Change from baseline in insulin resistance (HOMA-IR) | Insulin resistance will be determined by HOMA-IR using plasma glucose and insulin. | Participants will be followed for 4 months. Measurements will be done before and after 4 months |
| Changes from baseline in lipid profile | HDL-cholesterol in mg/dL, LDL-cholesterol in mg/dL, triglycerides in mg/dL, and total cholesterol in mg/dL will be measured | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in blood pressure | Systolic and diastolic blood pressure will be measured using an automated device, after 5minutes of resting, in triplicate with a 1-minute interval between each measurement. The first measurement will be discarded, and the average of the two other measurements will be used for analysis. | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in body weight | Body weight in kg will be measured, with the participants wearing light clothing and no shoes, using a high-quality electronic scale | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in waist circumference | Waist circumference in cm will be measured at the mid-point between the lowest rib and the iliac crest using an anthropometric tape | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in BMI | Weight and height will be combined to report BMI in kg/m^2 | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in body composition | Body composition will be assessed through TANITA | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in the Functional Assessment of Cancer Therapy - Breast questionnaire | Quality of life will be assessed through the Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire. It is a 37-item instrument designed to measure 5 domains (physical, social, emotional, functional well-being, and breast-cancer subscale) of health-related quality of life in patients with breast cancer. Subscale scores will be added to derive:
The higher the score, the better the outcome. | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire | Fatigue will be assessed through the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire, a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Subscale scores will be added to derive total scores:
The higher the score, the better the outcome. | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in diet quality | Diet will be assessed using a validated semiquantitative food frequency questionnaire | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in severity of depressive symptoms | Severity of depressive symptoms will be assessed using the self-administered Patient Health Questionnaire-9 (PHQ-9), a nine-item instrument in which each item is scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher PHQ-9 scores indicate greater severity of depressive symptoms. | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| Change from baseline in the severity of anxiety symptoms | Severity of anxiety symptoms will be assessed using the self-administered Generalized Anxiety Disorder-7 (GAD-7) questionnaire, a seven-item instrument in which each item is scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher GAD-7 scores indicate greater severity of anxiety symptoms. | Participants will be followed for 4 months. Measurements will be done before and after 4 months. |
| D017437 |
| Skin and Connective Tissue Diseases |