Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

Study Overview
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Brief Summary
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In this study, it was aimed to evaluate the effect of the Mediterranean diet on body composition, oxidant stress and proinflammatory markers in overweight and obese breast cancer women.

Detailed Description
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Breast cancer is the most common type of cancer among women in both developed and developing countries and is the leading cause of cancer death among women worldwide. Breast cancer is a disease that can develop and progress for various reasons. In addition to unchangeable factors such as increasing age and genotype, modifiable factors such as smoking, alcohol consumption, lack of physical activity, malnutrition, and obesity play a role in the pathogenesis of the disease. Breast cancer risk increases with increasing body mass index (BMI) in postmenopausal women. Chronic inflammation in obesity is associated with an increase in the release of proinflammatory factors (such as TNF-α, IL-1, IL-6). This situation; It is a risk factor for many types of cancer such as colon, stomach, breast and prostate carcinomas and supports a cause-effect relationship between obesity and cancer. These proinflammatory factors act as signal converters for tumor growth and progression. Obese women have elevated levels of TNF-α and IL-6 in the circulation, and this is associated with the development and progression of breast tumors. The Mediterranean Diet, which consists of high amounts of monounsaturated fatty acids, fruits, vegetables and whole grains, has been widely evaluated and indicated as an important factor in preventing tumor formation from inflammatory pathways. Weight loss improves the antitumor immune system, lowers estrogen levels, reduces the risk of breast cancer and has been associated with better outcomes in obese patients. Lifestyle intervention studies strongly suggest that weight loss is possible and observational studies can actually improve breast cancer survival.In this regard, a healthy lifestyle and diet are the first steps to prevent breast cancer.

Official Title
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Evaluation of the Effect of Mediterranean Diet on Body Composition, Oxidant Stress and Proinflammatory Markers in Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old, BMI value to be ≥25 kg/m2, To be diagnosed with breast cancer stage I, II or III, Being a positive hormone receptor status, one of the biological subtypes of breast cancer, Having completed chemotherapy and / or radiotherapy treatment at least 6 months before starting the study, Not applying any treatment for body weight loss, Accepting to participate in the study, Perceiving disorder and not having communication problems. Exclusion Criteria: Being under the age of 18 and over the age of 65, BMI value to be 40 kg/m2, Having advanced stage breast cancer (IV and V), Being diagnosed with cancer or metastasis in other organs, Being one of the biological subtypes of breast cancer, hormone receptor status being negative, Using antioxidant vitamin-mineral supplements, Using herbal supplements, Being pregnant or planning a pregnancy, To stop working after starting diet therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet<br>In the study, the participants were applied a diet compatible with the Mediterranean diet for 8 weeks. | Behavioral: Mediterranean Diet<br>* While calculating the energy of the Mediterranean diet applied to the individuals participating in the study, Mifflin-St. Jeor equation is used. The macronutrient composition of the Mediterranean diet was calculated as 36-40% fat, 40-45% carbohydrate and 15-20% protein. This diet is enriched with natural foods (fruits, vegetables, legumes, whole grain foods, fish, olive oil and oilseeds such as walnuts and almonds). In addition, anthropometric measurements and body composition analysis of the participants were performed both at the beginning and at the end of the study, and some biochemical parameters (IL-6, TNF-α, CRP, MDA, TAS, TOS and routine blood parameters) were evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Body weight (kg) was measured using the InBody 270 brand device. | Baseline, 8 weeks | 
| Change in body mass indexs | The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m^2, resulting from mass in kilograms and height in metres. | Baseline, 8 weeks | 
| Change in fat mass measured by bioelectrical impedance analyzer | Fat mass (kg) was measured using the InBody 270 brand device. | Baseline, 8 weeks | 
| Change in fat-free mass measured by bioelectrical impedance analyzer | Fat-free mass (kg) was measured using the InBody 270 brand device. | Baseline, 8 weeks | 
| Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer | RMR (kcal) was measured using the InBody 270 brand device. | Baseline, 8 weeks | 
| Change in interleukin 6 (IL-6) | Blood was drawn from participants for assessment of IL-6 (pg/mL) at the beginning and end of the study after fasting for at least 8 hours | Baseline, 8 weeks | 
| Change in tumor necrosis factor alpha (TNF-α) | Blood was drawn from participants for assessment of TNF-α (pg/mL) at the beginning and end of the study after fasting for at least 8 hours | Baseline, 8 weeks | 
| Change in malondialdehyde (MDA) | Blood was drawn from participants for assessment of MDA (mmol/L) at the beginning and end of the study after fasting for at least 8 hours | Baseline, 8 weeks | 
| Change in total antioxidant status (TAS) | Blood was drawn from participants for assessment of TAS (mmol/L) at the beginning and end of the study after fasting for at least 8 hours | Baseline, 8 weeks | 
| Change in total oxidant status (TOS) | Blood was drawn from participants for assessment of TOS (µmol/L) at the beginning and end of the study after fasting for at least 8 hours | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference | Waist circumference (cm) was measured with a non-stretch tape measure. | Baseline, 8 weeks | 
| Change in hip circumference | Hip circumference (cm) was measured with a non-stretch tape measure. | Baseline, 8 weeks | 
| Change in dietary inflammatory index (DII) | Dietary inflammatory index (DII) was calculated with 3-day food consumption record. | Baseline, 8 weeks | 
| Change in oxidative stress index (OSI) | The oxidative stress index (OSI) value expressed as a percentage of the ratio of serum total oxidant status (TOS) levels to total antioxidant status (TAS) levels was calculated. | Baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Composition, Diet therapy, Mediterranean diet, Oxidant Stress markers, Proinflammatory markers