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

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)

Overview

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)

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.

Interventions

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

Primary outcome measures

• Lipid mediators profile [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3]

Secondary outcome measures (12)

• Body weight [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Height [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Body mass index [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Hip circumference [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Waist circumference [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Leg circumference [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Appendicular Skeletal Muscle Mass [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Fat mass percentage [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Fat mass (g) [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Lean mass [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Fat-free mass [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]
• Visceral adipose tissue [Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Spain · 2 centers

• Center for Nutrition Research — Pamplona
• Clínica Universidad de Navarra — Pamplona

Identifiers

NCT: NCT07447440 · RESOLBE (2024.153mod1)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗