Observational study (baseline)Observational study (baseline and 1 year)
Observational study (baseline): Data will be collected at a single time point.
Observational study (baseline and 1 year): Data will be collected at two time points during the study period.
Study summary
The main objective of this project is to determine the possible association between the levels of certain bioactive lipids, which the body produces from dietary fatty acids, and tumor characteristics in breast cancer patients, as well as their relationship with overweight/obesity.
Specific objectives are:
* To analyse anthropometric and body composition changes.
* To evaluate physical activity level.
* To determine dietary profile.
* To determine the adherence to Mediterranean dietary pattern.
* To assess the quality of life.
* To determine levels of specialized pro-resolving lipid mediators
The target sample size is 60 subjects. Participants will be allocated in four groups:
* Group 1: Postmenopausal healthy women with overweight/obesity (n=15)
* Group 2: Postmenopausal healthy women with normoweight (n=15)
* Group 3: Postmenopausal women with breast cancer and overweight/obesity (n=15)
* Group 4: Postmenopausal women with breast cancer and normoweight (n=15)
Eligibility
Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
Accepted
HEALTHY PARTICIPANTS:
Inclusion Criteria:
* Postmenopause (al least 1 year).
* Normoweight or overweight/obesity.
* No personal history of cancer.
* Stable weight over the last 3 months (±5%).
* Willing to sign the informed consent and comply with all study procedures.
Exclusion Criteria:
* Personal history of cancer.
* Current weight loss treatment (diet, supplementation, surgery, others...).
* Bariatric surgery.
* No stable pharmacological treatment for at least 3 months.
* Diabetes treatment and hormone replacement therapy.
* Relevant functional or structural abnormalities of the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc.
* High alcohol intake, more than 14 units per week for women and 20 units per week for men.
* Surgical interventions resulting in permanent sequelae of the gastrointestinal tract.
* Liver disease, except for non-alcoholic fatty liver disease.
* Cognitive and/or psychiatric impairment.
* Poor compliance or difficulty following study procedures.
BREAST CANCER PARTICIPANTS:
Inclusion Criteria:
* Postmenopause (at least 1 year).
* Normoweight or overweight/obesity.
* Luminal subtype breast cancer, stages I-II, who require tumor resection and do not require preoperative treatment.
* Willing to sign the informed consent and comply with all study procedures.
Exclusion Criteria:
* Luminal subtype breast cancer stages over than II or other type of breast cancer.
* Require preoperative treatment.
Primary outcome measure(s)
Lipid mediators profile — Clinical Investigation Day 1 and Clinical Investigation Day 3 Lipid mediators will be analysed by targeted lipidomic method.
Trial sites (2)
Facility
City
Region
Status
Center for Nutrition Research
Pamplona
Navarre
Recruiting
Clínica Universidad de Navarra
Pamplona
Navarre
Recruiting
More Clinica Universidad de Navarra, Universidad de Navarra trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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