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NCT Number: NCT07447440

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

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)

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Key information

Conditions

Breast Cancer Body Weight Breast Diseases Breast Neoplasms Health, Subjective Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Center for Nutrition Research, Pamplona, Navarre, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Lipid mediators profile

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3

    Lipid mediators will be analysed by targeted lipidomic method.

Secondary outcomes

  1. Body weight

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  2. Height

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  3. Body mass index

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

    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.

  4. Hip circumference

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  5. Waist circumference

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  6. Leg circumference

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  7. Appendicular Skeletal Muscle Mass

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  8. Fat mass percentage

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  9. Fat mass (g)

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  10. Lean mass

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  11. Fat-free mass

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  12. Visceral adipose tissue

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  13. Android mass

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  14. Android fat

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  15. Subcutaneous adipose tissue

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  16. Total bone mineral density

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  17. Forearm bone mineral density

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

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

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  19. Femoral neck bone mineral density

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  20. Total femur bone mineral density

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  21. Glucose concentration

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  22. Insulin concentration

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  23. HOMA index (Homeostatic Model Assessment index)

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  24. Total cholesterol

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  25. High density lipoprotein cholesterol (HDL-c)

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  26. Low lipoprotein cholesterol (LDL-c)

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  27. Triglyceride levels

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  28. Adiponectin

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  29. Leptin

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  30. Tumor necrosis factor alpha (TNF-alpha)

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  31. Free fatty acids

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  32. Lipocalin

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  33. IL-6 (interleukine-6)

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  34. IL-8 (interleukine-8)

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  35. Physical activity level by acelerometers

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  36. Physical activity level by questoinnaire

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  37. Dietary profile

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  38. Mental and physical quality of life

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

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

  39. Adherence to Mediterranean dietary pattern

    Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

María Jesús Moreno-Aliaga, PhD

CONTACT

[email protected]

+34948425600 ext. 806558

Miguel Burgos, PhD

CONTACT

[email protected]

+34948425600 ext. 806225

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study 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)

Acronym: RESOLBE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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