Avocado Consumption and Cellular Aging in Breast Cancer Survivors
NCT ID: NCT07097155
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-09-30
2027-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Daily Avocado Consumption
Participants follow their usual diet and consume one avocado per day for 4 months
Control - Usual Diet
Participants allocated to the control group will be advised to follow their usual diet. Avocado consumption will not be encouraged.
No interventions assigned to this group
Interventions
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Daily Avocado Consumption
Participants follow their usual diet and consume one avocado per day for 4 months
Eligibility Criteria
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Inclusion Criteria
* 40-65 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.
Exclusion Criteria
* 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.
40 Years
65 Years
FEMALE
No
Sponsors
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Institut Investigacio Sanitaria Pere Virgili
OTHER
Responsible Party
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Nerea Becerra Tomás
Principal Investigator
Locations
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Unit for Public Health and Nutritional Epidemiology, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili
Reus, Tarragona, Spain
Countries
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Central Contacts
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Facility Contacts
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Nerea Becerra Tomás, PhD
Role: primary
Other Identifiers
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PI24/00556
Identifier Type: -
Identifier Source: org_study_id