NCT07447440 Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases
| NCT ID | NCT07447440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-10-15 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Miguel Burgos, PhD
PRINCIPAL INVESTIGATOR
Center for Nutrition Research
Frequently Asked Questions
Who can join the NCT07447440 clinical trial?
This trial is open to female participants only, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07447440 currently recruiting?
Yes, NCT07447440 is actively recruiting participants. Contact the research team at mburgosloz@unav.es for enrollment information.
Where is the NCT07447440 trial being conducted?
This trial is being conducted at Pamplona, Spain, Pamplona, Spain.
Who is sponsoring the NCT07447440 clinical trial?
NCT07447440 is sponsored by Clinica Universidad de Navarra, Universidad de Navarra. The principal investigator is Miguel Burgos, PhD at Center for Nutrition Research. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.