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Breast CancerRESOLBENCT07447440

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

An observational study of Breast Cancer and Health, Subjective, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Health, Subjective, Obesity
What is being tested?
Observational study (baseline) and Observational study (baseline and 1 year)
How many people
60 participants
Where
2 sitesSpain
Study dates
15 Oct 2025to 30 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Postmenopuasal women.

Who may be able to join

  • 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.
  • Postmenopause (at least 1 year).
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  • 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.

Who cannot join

  • 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.
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  • 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:
  • Luminal subtype breast cancer stages over than II or other type of breast cancer.
  • Require preoperative treatment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Miguel Burgos, PhD contact

+34948425600 ext. 806225

mburgosloz@unav.es

María Jesús Moreno-Aliaga, PhD contact

+34948425600 ext. 806558

mjmoreno@unav.es

Spain2 sites, 2 recruiting

  • Center for Nutrition Research

    Pamplona, Navarre, 31008

    Miguel Burgos, PhD, +34948425600 ext. 806225, mburgosloz@unav.es

    María Jesús Moreno-Aliaga, PhD, +34948425600 ext. 806558, mjmoreno@unav.es

    Recruiting

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

    Begoña Olartecoechea, PhD, +34948 25 54 00, bolarteco@unav.es

    Ángel Vizcay, PhD, +34948 25 54 00, avizcay@unav.es

    Recruiting

Other trials in Spain

About this study

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)

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:

Read more
  • 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)
Read the 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.
Being tested
Observational study (baseline), Observational study (baseline and 1 year)
Keywords
Breast, Cancer, Postmenopause, Lipid mediators, Obesity
Medical subject headings
Breast Neoplasms, Obesity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational study (baseline)Other

    Data will be collected at a single time point.

  • Observational study (baseline and 1 year)Other

    Data will be collected at two time points during the study period.

Study groups in NCT07447440
Study groupRoleWhat they receive
Group 1Postmenopausal healthy women with overweight/obesity.
Receives: Other: Observational study (baseline)
Group 2Postmenopausal healthy women with normoweight.
Receives: Other: Observational study (baseline)
Group 3Postmenopausal women with breast cancer and overweight/obesity
Receives: Other: Observational study (baseline and 1 year)
Group 4Postmenopausal women with breast cancer and normoweight.
Receives: Other: Observational study (baseline and 1 year)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipid mediators profile

    Lipid mediators will be analysed by targeted lipidomic method.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3

Secondary outcomes (39)

  1. Body weight

    Weight of participants will be measured by bioimpedance and densitometry and reported in kg

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  2. Height

    Height of participants will be measured by stadiometer and reported in m.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  3. Body mass index

    Body mass index will be calculated as follows: weight (kilograms)/ height (m)2 and will be also measured by densitometry and reported in kg/m2.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  4. Hip circumference

    Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  5. Waist circumference

    Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  6. Leg circumference

    Leg circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  7. Appendicular Skeletal Muscle Mass

    Appendicular Skeletal Muscle Mass will be calculated by the following formula and reported in kg/m2: ([musc_apend_kg]/([height_m]*[height_m)

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  8. Fat mass percentage

    Fat mass of participants will be analyzed by densitometry and reported in percentage.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  9. Fat mass (g)

    Fat mass of participants will be analyzed by densitometry and reported in grams.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  10. Lean mass

    Lean mass of participants will be analyzed by densitometry and reported in grams.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  11. Fat-free mass

    Fat-free mass of participants will be analyzed by densitometry and reported in grams.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  12. Visceral adipose tissue

    Visceral adipose tissue of participants will be analyzed by densitometry and reported in grams.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  13. Android mass

    Android mass of participants will be analyzed by densitometry and reported in kg.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  14. Android fat

    Android fat of participants will be analyzed by densitometry and reported in grams.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  15. Subcutaneous adipose tissue

    Subcutaneous adipose tissue of participants will be analyzed by densitometry and reported in grams.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  16. Total bone mineral density

    Total bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  17. Forearm bone mineral density

    Forearm bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  18. Lumbar spine (L1-L4) bone mineral density

    Lumbar spine (L1-L4) bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  19. Femoral neck bone mineral density

    Femoral neck bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  20. Total femur bone mineral density

    Total femur bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  21. Glucose concentration

    Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  22. Insulin concentration

    Blood insulin concentration will be analyzed after an overnight fast by ELISA kit.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  23. HOMA index (Homeostatic Model Assessment index)

    HOMA index will be calculated as follows: HOMA-IR = [fasting glucose (mmol/L) x fasting insulin (μU/ml)] / 22.5.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  24. Total cholesterol

    Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  25. High density lipoprotein cholesterol (HDL-c)

    Blood HDL-c levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  26. Low lipoprotein cholesterol (LDL-c)

    LDL-c levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  27. Triglyceride levels

    Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  28. Adiponectin

    Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit in µg/ml.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  29. Leptin

    Blood leptine concentration will be analyzed after an overnight fast by ELISA kit in ng/mL.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  30. Tumor necrosis factor alpha (TNF-alpha)

    Blood TNF-alpha concentration will be analyzed after an overnight fast by ELISA kit.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  31. Free fatty acids

    Free fatty acids levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mmol/L.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  32. Lipocalin

    Lipocalin concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/mL.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  33. IL-6 (interleukine-6)

    Blood IL-6 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  34. IL-8 (interleukine-8)

    Blood IL-8 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  35. Physical activity level by acelerometers

    Physical activity will be measured by accelerometers that will be pleaced for 7 days. Results will be measured in MET.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  36. Physical activity level by questoinnaire

    Physical activity will be measured using validated questionnaire of SUN project, which estimates the total physical activity in MET.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  37. Dietary profile

    Dietary profile (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  38. Mental and physical quality of life

    Quality of life will be analysed by SF-36 questionnaire with 36 items grouped into 8 main dimensions or domains.

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

  39. Adherence to Mediterranean dietary pattern

    Adherence to Mediterranean dietary pattern will be analysed by MEDAS (14 items). Each question is scored 0 or 1 point. The total score is the sum of the 14 items.

    Interpretation:

    0-5 points: low adherence to the Mediterranean diet

    6-9 points: moderate adherence

    ≥10 points: high adherence

    Measured: Clinical Investigation Day 1 and Clinical Investigation Day 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start15 Oct 2025
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07447440
Sponsor's protocol ID
RESOLBE (2024.153mod1)
Acronym
RESOLBE
Status last verified
Mar 2026
First submitted
25 Feb 2026
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Health, Subjective, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Miguel Burgos, PhD (+34948425600 ext. 806225, mburgosloz@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipid mediators profile (time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07447440.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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