Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases (RESOLBE)

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:

• 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)

Study Overview

• Status: Recruiting
• Conditions: Obesity; Breast Cancer; Health, Subjective
• Intervention / Treatment: Other: Observational study (baseline); Other: Observational study (baseline and 1 year)

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Miguel Burgos, PhD; Phone Number: 806225 +34948425600; Email: mburgosloz@unav.es
• Study Contact Backup: Name: María Jesús Moreno-Aliaga, PhD; Phone Number: 806558 +34948425600; Email: mjmoreno@unav.es

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Clinica Universidad de Navarra
      • Contact: Begoña Olartecoechea, PhD; Phone Number: +34948 25 54 00; Email: bolarteco@unav.es
      • Contact: Ángel Vizcay, PhD; Phone Number: +34948 25 54 00; Email: avizcay@unav.es
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Center for Nutrition Research
      • Contact: Miguel Burgos, PhD; Phone Number: 806225 +34948425600; Email: mburgosloz@unav.es
      • Contact: María Jesús Moreno-Aliaga, PhD; Phone Number: 806558 +34948425600; Email: mjmoreno@unav.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Postmenopuasal women.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Postmenopausal healthy women with overweight/obesity.	Other: Observational study (baseline); Data will be collected at a single time point.
Group 2; Postmenopausal healthy women with normoweight.	Other: Observational study (baseline); Data will be collected at a single time point.
Group 3; Postmenopausal women with breast cancer and overweight/obesity	Other: Observational study (baseline and 1 year); Data will be collected at two time points during the study period.
Group 4; Postmenopausal women with breast cancer and normoweight.	Other: Observational study (baseline and 1 year); Data will be collected at two time points during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid mediators profile	Lipid mediators will be analysed by targeted lipidomic method.	Clinical Investigation Day 1 and Clinical Investigation Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Weight of participants will be measured by bioimpedance and densitometry and reported in kg	Clinical Investigation Day 1 and Clinical Investigation Day 3.
Height	Height of participants will be measured by stadiometer and reported in m.	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.	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.	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.	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.	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)	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.	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.	Clinical Investigation Day 1 and Clinical Investigation Day 3.
Lean mass	Lean mass of participants will be analyzed by densitometry and reported in grams.	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.	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.	Clinical Investigation Day 1 and Clinical Investigation Day 3.
Android mass	Android mass of participants will be analyzed by densitometry and reported in kg.	Clinical Investigation Day 1 and Clinical Investigation Day 3.
Android fat	Android fat of participants will be analyzed by densitometry and reported in grams.	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.	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.	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.	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.	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.	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.	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.	Clinical Investigation Day 1 and Clinical Investigation Day 3.
Insulin concentration	Blood insulin concentration will be analyzed after an overnight fast by ELISA kit.	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.	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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.	Clinical Investigation Day 1 and Clinical Investigation Day 3.
Dietary profile	Dietary profile (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.	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.	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.	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.	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	Clinical Investigation Day 1 and Clinical Investigation Day 3.

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Study Chair: Salomé Pérez, Center for Nutrition Research; Principal Investigator: Miguel Burgos, PhD, Center for Nutrition Research; Principal Investigator: María Jesús Moreno-Aliaga, PhD, Center for Nutrition Research; Study Chair: María Soledad García-Unciti, PhD, Center for Nutrition Research; Study Chair: Idoia Ibero-Baraibar, PhD, Center for Nutrition Research; Study Chair: Iosune Zubieta, Center for Nutrition Research; Study Chair: Asunción Redín, Center for Nutrition Research; Study Chair: Andrea Lara, Center for Nutrition Research; Study Chair: María Pilar Lostao, PhD, Center for Nutrition Research; Study Chair: Natalia Rodríguez-Spiteri, PhD, Clinica Universidad de Navarra; Study Chair: Begoña Olartecoechea, PhD, Clinica Universidad de Navarra; Study Chair: Ángel Vizcay, PhD, Clinica Universidad de Navarra; Study Chair: Marta Santisteban, PhD, Clinica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Cancer; Postmenopause; Breast; Lipid mediators
• Additional Relevant MeSH Terms: Nutrition Disorders; Neoplasms by Site; Overnutrition; Body Weight; Skin Diseases; Breast Diseases; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Neoplasms; Obesity; Breast Neoplasms; Investigative Techniques; Methods; Observation; BaseLine dental cement
• Other Study ID Numbers: RESOLBE (2024.153mod1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No