RecruitingNCT07447440RESOLBEUpdated Mar 11, 2026

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

An observational study in Breast Cancer, Health, Subjective and Obesity, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Recruiting at 2 sites in Spain. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Observational

From the registry’s dates

Started Oct 2025; still recruiting 1 year later.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 60
Sex: Female

Study 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)

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.

Conditions studied

Breast Cancer
Health, Subjective
Obesity

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Keywords

Breast
Cancer
Postmenopause
Lipid mediators
Obesity

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 60 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 160 studies on the registry; 36 are open to participants now.

Browse Clinica Universidad de Navarra, Universidad de Navarra studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Postmenopuasal women.

Eligibility criteria

HEALTHY PARTICIPANTS:

Inclusion Criteria:

(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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 60 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

Group 1
Postmenopausal healthy women with overweight/obesity.
Other: Observational study (baseline)
Group 2
Postmenopausal healthy women with normoweight.
Other: Observational study (baseline)
Group 3
Postmenopausal women with breast cancer and overweight/obesity
Other: Observational study (baseline and 1 year)
Group 4
Postmenopausal women with breast cancer and normoweight.
Other: Observational study (baseline and 1 year)

Interventions

OtherObservational study (baseline)
Data will be collected at a single time point.
OtherObservational study (baseline and 1 year)
Data will be collected at two time points during the study period.

What researchers measure

Primary outcomes

Lipid mediators profile
Lipid mediators will be analysed by targeted lipidomic method.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3

Secondary outcomes

Body weight
Weight of participants will be measured by bioimpedance and densitometry and reported in kg
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Height
Height of participants will be measured by stadiometer and reported in m.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 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.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Hip circumference
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Waist circumference
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Leg circumference
Leg circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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)
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Fat mass percentage
Fat mass of participants will be analyzed by densitometry and reported in percentage.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Fat mass (g)
Fat mass of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Lean mass
Lean mass of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Fat-free mass
Fat-free mass of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Visceral adipose tissue
Visceral adipose tissue of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Android mass
Android mass of participants will be analyzed by densitometry and reported in kg.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Android fat
Android fat of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Subcutaneous adipose tissue
Subcutaneous adipose tissue of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Total bone mineral density
Total bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Forearm bone mineral density
Forearm bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Femoral neck bone mineral density
Femoral neck bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Total femur bone mineral density
Total femur bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Glucose concentration
Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Insulin concentration
Blood insulin concentration will be analyzed after an overnight fast by ELISA kit.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Total cholesterol
Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Low lipoprotein cholesterol (LDL-c)
LDL-c levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Triglyceride levels
Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Adiponectin
Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit in µg/ml.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Leptin
Blood leptine concentration will be analyzed after an overnight fast by ELISA kit in ng/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Tumor necrosis factor alpha (TNF-alpha)
Blood TNF-alpha concentration will be analyzed after an overnight fast by ELISA kit.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Free fatty acids
Free fatty acids levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mmol/L.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Lipocalin
Lipocalin concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
IL-6 (interleukine-6)
Blood IL-6 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
IL-8 (interleukine-8)
Blood IL-8 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Physical activity level by questoinnaire
Physical activity will be measured using validated questionnaire of SUN project, which estimates the total physical activity in MET.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Dietary profile
Dietary profile (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

Study locations

2 of 2 sites recruiting

Center for Nutrition Research
Pamplona, Navarre 31008, Spain
3 other open studies at this site →
Recruiting
- Miguel Burgos, PhD · Contact · mburgosloz@unav.es · +34948425600
- María Jesús Moreno-Aliaga, PhD · Contact · mjmoreno@unav.es · +34948425600
Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre 31008, Spain
131 other open studies at this site →
Recruiting
- Begoña Olartecoechea, PhD · Contact · bolarteco@unav.es · +34948 25 54 00
- Ángel Vizcay, PhD · Contact · avizcay@unav.es · +34948 25 54 00
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Nov 2027, 25 months after the start.

Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 25 months is below that.

Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 25, 2026
First posted: Mar 3, 2026
StartActual: Oct 15, 2025
Primary completionEst.: Nov 30, 2027
CompletionEst.: Dec 30, 2027
Last update: Mar 11, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07447440
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Responsible party: Sponsor
First posted: Mar 3, 2026
Start date: Oct 15, 2025
Primary completion: Nov 30, 2027 (estimated)
Completion: Dec 30, 2027 (estimated)
Last update: Mar 11, 2026

Study contacts

Miguel Burgos, PhD

Contact

mburgosloz@unav.es

+34948425600 ext. 806225

María Jesús Moreno-Aliaga, PhD

Contact

mjmoreno@unav.es

+34948425600 ext. 806558

Miguel Burgos, PhD

principal investigator · Center for Nutrition Research

María Jesús Moreno-Aliaga, PhD

principal investigator · Center for Nutrition Research

María Soledad García-Unciti, PhD