Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases
Recruiting · NCT07447440 · Observational (researchers observe without assigning treatment) · Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
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.
Where it is running
2 locations listed.
- Center for Nutrition Research - Pamplona, Navarre, Spain
- Clínica Universidad de Navarra - Pamplona, Navarre, Spain