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)
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.
Study Type
OBSERVATIONAL
Enrollment
60
Data will be collected at a single time point.
Data will be collected at two time points during the study period.
Center for Nutrition Research
Pamplona, Navarre, Spain
RECRUITINGClínica Universidad de Navarra
Pamplona, Navarre, Spain
RECRUITINGLipid mediators profile
Lipid mediators will be analysed by targeted lipidomic method.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3
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.
Height
Height of participants will be measured by stadiometer and reported in m.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 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.
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.
Waist circumference
Waist 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.
Leg circumference
Leg 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.
Appendicular Skeletal Muscle Mass
Appendicular Skeletal Muscle Mass will be calculated by the following formula and reported in kg/m2: (\[musc\_apend\_kg\]/(\[height\_m\]\*\[height\_m)
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Fat mass percentage
Fat mass of participants will be analyzed by densitometry and reported in percentage.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Fat mass (g)
Fat mass of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Lean mass
Lean mass of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Fat-free mass
Fat-free mass of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Visceral adipose tissue
Visceral adipose tissue of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Android mass
Android mass of participants will be analyzed by densitometry and reported in kg.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Android fat
Android fat of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Subcutaneous adipose tissue
Subcutaneous adipose tissue of participants will be analyzed by densitometry and reported in grams.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Total bone mineral density
Total bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Forearm bone mineral density
Forearm bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Lumbar spine (L1-L4) bone mineral density
Lumbar spine (L1-L4) bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Femoral neck bone mineral density
Femoral neck bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Total femur bone mineral density
Total femur bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Glucose concentration
Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Insulin concentration
Blood insulin concentration will be analyzed after an overnight fast by ELISA kit.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
HOMA index (Homeostatic Model Assessment index)
HOMA index will be calculated as follows: HOMA-IR = \[fasting glucose (mmol/L) x fasting insulin (μU/ml)\] / 22.5.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Total cholesterol
Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
High density lipoprotein cholesterol (HDL-c)
Blood HDL-c levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Low lipoprotein cholesterol (LDL-c)
LDL-c levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Triglyceride levels
Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Adiponectin
Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit in µg/ml.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Leptin
Blood leptine concentration will be analyzed after an overnight fast by ELISA kit in ng/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Tumor necrosis factor alpha (TNF-alpha)
Blood TNF-alpha concentration will be analyzed after an overnight fast by ELISA kit.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Free fatty acids
Free fatty acids levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mmol/L.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Lipocalin
Lipocalin concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
IL-6 (interleukine-6)
Blood IL-6 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
IL-8 (interleukine-8)
Blood IL-8 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Physical activity level by acelerometers
Physical activity will be measured by accelerometers that will be pleaced for 7 days. Results will be measured in MET.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Physical activity level by questoinnaire
Physical activity will be measured using validated questionnaire of SUN project, which estimates the total physical activity in MET.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Dietary profile
Dietary profile (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Mental and physical quality of life
Quality of life will be analysed by SF-36 questionnaire with 36 items grouped into 8 main dimensions or domains.
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
Adherence to Mediterranean dietary pattern
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
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 3.
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