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NCT Number: NCT07097155

Avocado Consumption and Cellular Aging in Breast Cancer Survivors

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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Key information

Conditions

Telomere Length Breast Cancer Females Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unit for Public Health and Nutritional Epidemiology, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili

Reus, Tarragona, 43201, Spain

Location status: Recruiting

Location contact

Nerea Becerra Tomás, PhD

CONTACT

[email protected]

+34977759334

Nerea Becerra Tomás, PhD

PRINCIPAL_INVESTIGATOR

Victoria Arija, Professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Daily Avocado Consumption

Other

Participants follow their usual diet and consume one avocado per day for 4 months

Primary outcomes

  1. Change from baseline in leukocyte telomere length

    Time frame: 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)

Secondary outcomes

  1. Change from baseline in telomerase activity

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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).

  2. Change from baseline in inflammatory markers

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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.

  3. Change from baseline in oxidative markers

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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.

Other outcomes

  1. Change from baseline in fasting glucose

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    Fasting glucose in mg/dL will be measured by standardized methods

  2. Change from baseline in glycated hemoglobin

    Time frame: 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

  3. Change from baseline in insulin resistance (HOMA-IR)

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months

    Insulin resistance will be determined by HOMA-IR using plasma glucose and insulin.

  4. Changes from baseline in lipid profile

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    HDL-cholesterol in mg/dL, LDL-cholesterol in mg/dL, triglycerides in mg/dL, and total cholesterol in mg/dL will be measured

  5. Change from baseline in blood pressure

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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.

  6. Change from baseline in body weight

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    Body weight in kg will be measured, with the participants wearing light clothing and no shoes, using a high-quality electronic scale

  7. Change from baseline in waist circumference

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    Waist circumference in cm will be measured at the mid-point between the lowest rib and the iliac crest using an anthropometric tape

  8. Change from baseline in BMI

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    Weight and height will be combined to report BMI in kg/m^2

  9. Change from baseline in body composition

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    Body composition will be assessed through TANITA

  10. Change from baseline in the Functional Assessment of Cancer Therapy - Breast questionnaire

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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:

    • FACT-B Trial Outcome Index (TOI): ranging from 0 to 96.
    • FACT-G total score: ranging from 0 to 108
    • FACT-B total score: ranging from 0 to 148

    The higher the score, the better the outcome.

  11. Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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:

    • FACIT-F Trial Outcome Index (TOI): ranging from 0 to 108
    • FACT-G total score: ranging from 0 to 108
    • FACIT-F total score: ranging from 0 to 160
    • Fatigue subscale: ranging from 0 to 52

    The higher the score, the better the outcome.

  12. Change from baseline in diet quality

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    Diet will be assessed using a validated semiquantitative food frequency questionnaire

  13. Change from baseline in severity of depressive symptoms

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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.

  14. Change from baseline in the severity of anxiety symptoms

    Time frame: Participants will be followed for 4 months. Measurements will be done before and after 4 months.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nerea Becerra Tomás, PhD

CONTACT

[email protected]

+34977759334

Victoria Arija, Professor

CONTACT

[email protected]

+34977759334

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Registry information

Official study title

Effect of Daily Avocado Consumption on Cellular Aging in Female Breast Cancer Survivors: The ACCA Study

Acronym: ACCA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
May 12, 2026

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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