Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorClinica Universidad de Navarra, Universidad de Navarra
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Postmenopause (al least 1 year).
Normoweight or overweight/obesity.
No personal history of cancer.
Stable weight over the last 3 months (±5%).
Disqualifiers
Personal history of cancer.
Current weight loss treatment (diet, supplementation, surgery, others...).
Bariatric surgery.
No stable pharmacological treatment for at least 3 months.
Trial population
Postmenopuasal women.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Observational study (baseline)
Other interventionData will be collected at a single time point.
Observational study (baseline and 1 year)
Other interventionData will be collected at two time points during the study period.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention
Group D: Group 41 intervention
Trial outcomes
Primary outcomes
1
Lipid mediators profile
Lipid mediators will be analysed by targeted lipidomic method.
Time frame
Clinical Investigation Day 1 and Clinical Investigation Day 3Secondary outcomes
1
Body weight
Weight of participants will be measured by bioimpedance and densitometry and reported in kg
Time frame
Clinical Investigation Day 1 and Clinical Investigation Day 3.2
Height
Height of participants will be measured by stadiometer and reported in m.
Time frame
Clinical Investigation Day 1 and Clinical Investigation Day 3.3
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.
Time frame
Clinical Investigation Day 1 and Clinical Investigation Day 3.4
Hip circumference
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm.
Time frame
Clinical Investigation Day 1 and Clinical Investigation Day 3.Sponsors and contacts
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Source ClinicalTrials.gov