NCT07447440

Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases

Unraveling the Role of Pro-Resolving Lipid Mediators of Inflammation and Their Receptors in Obesity-Associated Diseases: New Therapeutic Approaches for Maresin 1 (RESOLBE)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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)

Detailed description

Volunteers who wish to participate in the study will be informed about the procedures of the study. Volunteers who agree to participate will sign the informed consent form. Participants from Group 1 and Group 2 will visit nutritional intervention unit at Clinical Investigation Day 1 (day 1) and at Clinical Investigation Day 2 (day 8). Participants from Group 3 and Group 4 will visit nutritional intervention unit after surgery for tumor removal, at Clinical Investigation Day 1 (day 1), at Clinical Investigation Day 2 (day 8), at Clinical Investigation Day 3 (1 year) and at Clinical Investigation Day 4 (1 year + day 8). * Clinical Investigation Day 1 and 3: anthropometric and body composition measurements, delivery of questionnaires , blood extraction, placement of accelerometer . * Clinical Investigation Day 2 and 4: reception of accelerometer and collection of completed questionnaires.

Conditions

• Breast Cancer
• Health, Subjective
• Obesity

Interventions

Type	Name	Description
OTHER	Observational study (baseline)	Data will be collected at a single time point.
OTHER	Observational study (baseline and 1 year)	Data will be collected at two time points during the study period.

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-11-30
• Completion: 2027-12-30
• First posted: 2026-03-03
• Last updated: 2026-03-11

Locations

2 sites across 1 country: Spain