Role of Pro-Resolving Lipid Mediators in Obesity-Associat... | NCT07447440

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

NCT07447440

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Status

Recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Breast Cancer
Health, Subjective
Obesity

Interventions

Observational study (baseline)
Observational study (baseline and 1 year)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2025Actual

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Feb 25, 2026

First Submission Date that Met QC Criteria

Feb 25, 2026

First Posted Date

Mar 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Description Module

Brief 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)

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Observational study (baseline)	Other	Data will be collected at a single time point.	Group 1 Group 2

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Postmenopuasal women.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miguel Burgos, PhD	Contact	+34948425600	806225	mburgosloz@unav.es
María Jesús Moreno-Aliaga, PhD	Contact	+34948425600	806558	mjmoreno@unav.es

Overall Officials

Name	Affiliation	Role
Miguel Burgos, PhD	Center for Nutrition Research	Principal Investigator
María Jesús Moreno-Aliaga, PhD	Center for Nutrition Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Nutrition Research	Recruiting	Pamplona	Navarre	31008	Spain

ID	Term
D001943	Breast Neoplasms
D009765	Obesity
D009369	Neoplasms

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D019370	Observation
C074807	BaseLine dental cement

ID	Term
D008722	Methods
D008919	Investigative Techniques