Pro-resolving lipid mediators in postmenopausal women with and without breast cancer
Official title: Unraveling the Role of Pro-Resolving Lipid Mediators of Inflammation and Their Receptors in Obesity-Associated Diseases: New Therapeutic Approaches for Maresin 1 (RESOLBE)
Run by Clinica Universidad de Navarra, Universidad de Navarra · NCT07447440 · Data updated 2026-11-12
This project will test whether levels of certain inflammation-resolving fats made from dietary fatty acids differ between postmenopausal women with or without breast cancer and with or without overweight.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra Academic / other |
| Locations | 2 sites (Pamplona, Navarre and 1 other locations) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | November 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07447440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Postmenopausal women (at least 1 year since last period) who are willing to sign informed consent and are either healthy or have had recent breast tumor surgery, and who are normoweight or overweight/obese with stable weight.
✕Probably not a fit
Men, premenopausal women, people currently undergoing weight-loss treatments or certain excluded medical therapies (for example diabetes treatment or recent hormone replacement), and those unable to attend the required visits are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study enrolling 60 postmenopausal women divided into four groups by breast cancer status and weight (normoweight vs overweight/obesity). Participants will undergo anthropometry and body composition measurements, complete dietary and quality-of-life questionnaires, wear an accelerometer to measure activity, and provide blood samples for specialized pro-resolving lipid mediator measurement. Healthy participants have two visits over one week, while women with breast cancer have baseline visits after surgery and repeat measures at one year. The study compares lipid mediator levels and correlates them with tumor characteristics, body composition, diet, activity and quality-of-life measures.
Why it matters
Potential benefit: If successful, the findings could identify lipid markers that help personalize prevention or monitoring of obesity-related breast cancer and inform dietary or lifestyle strategies.
How similar studies have gone: Prior studies have linked specialized pro-resolving mediators to inflammation and cancer biology, but applying these lipid measures specifically to obesity-associated breast cancer in postmenopausal women is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Center for Nutrition Research
Pamplona, Navarre, Spain Recruiting -
Clínica Universidad de Navarra
Pamplona, Navarre, Spain Recruiting
Study contacts
- Principal investigator: Miguel Burgos, PhD — Center for Nutrition Research
- Study coordinator: Miguel Burgos, PhD
- Email: mburgosloz@unav.es
- Phone: +34948425600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.