Avocado Consumption and Cellular Aging in Breast Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorInstitut Investigacio Sanitaria Pere Virgili
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Metastasis;
Ductal carcinoma or lobular carcinoma in situ;
Breast cancer recurrence;
Cancer diagnosis other than breast cancer or non-melanoma skin cancer;
Trial design
Design model
Parallel
Treatments tested in this trial
Daily Avocado Consumption
Other interventionParticipants follow their usual diet and consume one avocado per day for 4 months
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Daily Avocado ConsumptionExperimental treatment 1 intervention
Group B: Control - Usual DietNo intervention 0 interventions
Trial outcomes
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)
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months.Secondary outcomes
1
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).
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months.2
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.
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months.3
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.
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months.Other outcomes
1
Change from baseline in fasting glucose
Fasting glucose in mg/dL will be measured by standardized methods
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months.2
Change from baseline in glycated hemoglobin
glycated hemoglobin (HbA1c) in % will be measured by standardized methods
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months3
Change from baseline in insulin resistance (HOMA-IR)
Insulin resistance will be determined by HOMA-IR using plasma glucose and insulin.
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months4
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
Time frame
Participants will be followed for 4 months. Measurements will be done before and after 4 months.Sponsors and contacts
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Source ClinicalTrials.gov