Breast Cancer, Health, Subjective, Obesity
Conditions
Keywords
Breast, Cancer, Postmenopause, Lipid mediators, Obesity
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.
Interventions
OTHERObservational study (baseline)
Data will be collected at a single time point.
OTHERObservational study (baseline and 1 year)
Data will be collected at two time points during the study period.
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid mediators profile | Clinical Investigation Day 1 and Clinical Investigation Day 3 | Lipid mediators will be analysed by targeted lipidomic method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appendicular Skeletal Muscle Mass | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Appendicular Skeletal Muscle Mass will be calculated by the following formula and reported in kg/m2: (\[musc\_apend\_kg\]/(\[height\_m\]\*\[height\_m) |
| Fat mass percentage | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Fat mass of participants will be analyzed by densitometry and reported in percentage. |
| Waist circumference | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm. |
| Body weight | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Weight of participants will be measured by bioimpedance and densitometry and reported in kg |
| Height | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Height of participants will be measured by stadiometer and reported in m. |
| Body mass index | Clinical Investigation Day 1 and Clinical Investigation Day 3. | 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. |
| Hip circumference | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm. |
| Fat mass (g) | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Fat mass of participants will be analyzed by densitometry and reported in grams. |
| Lean mass | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Lean mass of participants will be analyzed by densitometry and reported in grams. |
| Fat-free mass | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Fat-free mass of participants will be analyzed by densitometry and reported in grams. |
| Visceral adipose tissue | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Visceral adipose tissue of participants will be analyzed by densitometry and reported in grams. |
| Android mass | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Android mass of participants will be analyzed by densitometry and reported in kg. |
| Android fat | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Android fat of participants will be analyzed by densitometry and reported in grams. |
| Subcutaneous adipose tissue | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Subcutaneous adipose tissue of participants will be analyzed by densitometry and reported in grams. |
| Total bone mineral density | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Total bone mineral density of participants will be analyzed by densitometry and reported in g/cm2. |
| Forearm bone mineral density | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Forearm bone mineral density of participants will be analyzed by densitometry and reported in g/cm2. |
| Lumbar spine (L1-L4) bone mineral density | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Lumbar spine (L1-L4) bone mineral density of participants will be analyzed by densitometry and reported in g/cm2. |
| Femoral neck bone mineral density | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Femoral neck bone mineral density of participants will be analyzed by densitometry and reported in g/cm2. |
| Total femur bone mineral density | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Total femur bone mineral density of participants will be analyzed by densitometry and reported in g/cm2. |
| Glucose concentration | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL. |
| Insulin concentration | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood insulin concentration will be analyzed after an overnight fast by ELISA kit. |
| HOMA index (Homeostatic Model Assessment index) | Clinical Investigation Day 1 and Clinical Investigation Day 3. | HOMA index will be calculated as follows: HOMA-IR = \[fasting glucose (mmol/L) x fasting insulin (μU/ml)\] / 22.5. |
| Total cholesterol | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL |
| High density lipoprotein cholesterol (HDL-c) | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood HDL-c levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL |
| Low lipoprotein cholesterol (LDL-c) | Clinical Investigation Day 1 and Clinical Investigation Day 3. | LDL-c levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL. |
| Triglyceride levels | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL. |
| Adiponectin | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit in µg/ml. |
| Leptin | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood leptine concentration will be analyzed after an overnight fast by ELISA kit in ng/mL. |
| Tumor necrosis factor alpha (TNF-alpha) | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood TNF-alpha concentration will be analyzed after an overnight fast by ELISA kit. |
| Free fatty acids | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Free fatty acids levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mmol/L. |
| Lipocalin | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Lipocalin concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/mL. |
| IL-6 (interleukine-6) | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood IL-6 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL. |
| IL-8 (interleukine-8) | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Blood IL-8 concentration will be analyzed after an overnight fast by ELISA kit in pg/mL. |
| Physical activity level by acelerometers | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Physical activity will be measured by accelerometers that will be pleaced for 7 days. Results will be measured in MET. |
| Physical activity level by questoinnaire | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Physical activity will be measured using validated questionnaire of SUN project, which estimates the total physical activity in MET. |
| Dietary profile | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Dietary profile (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire. |
| Mental and physical quality of life | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Quality of life will be analysed by SF-36 questionnaire with 36 items grouped into 8 main dimensions or domains. |
| Leg circumference | Clinical Investigation Day 1 and Clinical Investigation Day 3. | Leg circumference of participants in fasting condition will be analyzed by measuring tape and reported in cm. |
| Adherence to Mediterranean dietary pattern | Clinical Investigation Day 1 and Clinical Investigation Day 3. | 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 |
Countries
Spain
Contacts
CONTACTMiguel Burgos, PhD
CONTACTMaría Jesús Moreno-Aliaga, PhD
PRINCIPAL_INVESTIGATORMiguel Burgos, PhD
Center for Nutrition Research
PRINCIPAL_INVESTIGATORMaría Jesús Moreno-Aliaga, PhD
Center for Nutrition Research
STUDY_CHAIRMaría Soledad García-Unciti, PhD
Center for Nutrition Research
STUDY_CHAIRIdoia Ibero-Baraibar, PhD
Center for Nutrition Research
STUDY_CHAIRIosune Zubieta
Center for Nutrition Research
STUDY_CHAIRSalomé Pérez
Center for Nutrition Research
STUDY_CHAIRAsunción Redín
Center for Nutrition Research
STUDY_CHAIRAndrea Lara
Center for Nutrition Research
STUDY_CHAIRMaría Pilar Lostao, PhD
Center for Nutrition Research
STUDY_CHAIRNatalia Rodríguez-Spiteri, PhD
Clínica Universidad de Navarra
STUDY_CHAIRBegoña Olartecoechea, PhD
Clínica Universidad de Navarra
STUDY_CHAIRÁngel Vizcay, PhD
Clínica Universidad de Navarra
STUDY_CHAIRMarta Santisteban, PhD
Clínica Universidad de Navarra
Outcome results
None listed