Avocado Consumption and Cellular Aging in Breast Cancer Survivors

NCT07097155 | Recruiting

• 1 other identifier: PI24/00556
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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; 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, 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, quality of life, and diet) will be compared between the intervention and control groups using linear regression models.

Conditions

Telomere Length; Breast Cancer Females

Keywords

Avocado consumption; Telomere length; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

Other Outcomes (12)

• Change from baseline in fasting glucose

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

• Change from baseline in glycated hemoglobin

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

• Change from baseline in insulin resistance (HOMA-IR)

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

Study Arms (2)

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.

Other: Daily Avocado Consumption

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.

Interventions

Daily Avocado Consumption OTHER

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

Daily Avocado Consumption

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with primary breast cancer in stages I, II or III;
• years old at screening;
• Cancer treatment (radiotherapy and chemotherapy) completed ≥ 6 months but not more than 5 years at the time of recruitment;
• Currently consuming less than 2 avocados per week;
• Signed the informed consent letter.

You may not qualify if:

• 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);
• Use of plant sterols, mineral supplements, use of fibre supplements, fish oil, or antioxidants;
• 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.

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

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

Reus, Tarragona, 43201, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nerea Becerra Tomás, PhD

CONTACT

+34977759334; nerea.becerra@urv.cat

Victoria Arija, Professor

CONTACT

+34977759334; victoria.arija@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ES (1)