Actively Recruiting
Unraveling the Role of Pro-Resolving Lipid Mediators of Inflammation and Their Receptors in Obesity-Associated Diseases: New Therapeutic Approaches for Maresin 1 (RESOLBE)
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2026-03-11
60
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between bioactive lipids produced from dietary fats and tumor features in postmenopausal women with breast cancer, with a focus on how overweight or obesity may influence this. The study also aims to analyze body measurements, physical activity, diet, adherence to a Mediterranean diet, and quality of life in these women. This observational study includes both healthy women and those with breast cancer to better understand these factors. Participants are divided into four groups: healthy postmenopausal women with overweight or obesity, healthy postmenopausal women with normal weight, postmenopausal women with breast cancer and overweight or obesity, and postmenopausal women with breast cancer and normal weight. Groups 1 and 2 will have assessments at two visits (Day 1 and Day 8). Groups 3 and 4 will have additional visits after tumor surgery, with evaluations at Day 1, Day 8, 1 year, and 1 year plus 8 days. During study visits, researchers will measure body composition and anthropometric data, collect blood samples, provide and collect questionnaires, and use accelerometers to monitor physical activity. The primary outcome is the lipid mediator profile measured at Day 1 and 1 year. Secondary outcomes include various body measurements, metabolic markers, physical activity levels, dietary profiles, and quality of life assessments. Total study participation spans from initial assessments up to one year with follow-up visits.
CONDITIONS
Brief Title
Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal for at least 1 year
- Normoweight or overweight/obesity
- For healthy participants: no personal history of cancer
- For breast cancer participants: luminal subtype breast cancer, stages I-II, requiring tumor resection without preoperative treatment
- Stable weight over the last 3 months (±15%)
- Willing to sign informed consent and comply with study procedures
You will not qualify if you...
- Personal history of cancer (for healthy participants)
- Current weight loss treatments such as diet, supplements, or surgery
- Bariatric surgery
- No stable pharmacological treatment for at least 3 months
- Diabetes treatment or hormone replacement therapy
- Significant gastrointestinal abnormalities (malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux)
- High alcohol intake (more than 14 units per week for women)
- Surgical interventions causing permanent gastrointestinal sequelae
- Liver disease except non-alcoholic fatty liver disease
- Cognitive or psychiatric impairment
- Poor compliance or difficulty following study procedures
- Breast cancer stages above II or other breast cancer types
- Requirement for preoperative treatment in breast cancer participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants provide informed consent before any study procedures.
Duration - Day 1 and Day 8 for Groups 1 and 2; Day 1, Day 8, 1 year, and 1 year + 8 days for Groups 3 and 4
Participants undergo anthropometric and body composition measurements, complete questionnaires, have blood drawn, and wear an accelerometer to assess physical activity and dietary profiles.
2 visits at Day 1 and Day 8 for Groups 1 and 2; 4 visits at Day 1, Day 8, 1 year, and 1 year + 8 days for Groups 3 and 4 (in-person)
Duration - 1 year post-surgery plus 8 days
Participants in Groups 3 and 4 are monitored one year after surgery to assess changes in lipid mediators, body composition, physical activity, and quality of life.
2 visits (in-person) at 1 year and 1 year + 8 days for Groups 3 and 4
Trial Site Locations
Total: 2 locations
1
Center for Nutrition Research
Pamplona, Navarre, Spain, 31008
Actively Recruiting
2
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
M
Miguel Burgos, PhD
M
María Jesús Moreno-Aliaga, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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