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Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Behavioral: Mediterranean Diet
Registration Number
NCT04818996
Lead Sponsor
Aydin Adnan Menderes University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
25
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Mediterranean DietMediterranean DietIn the study, the participants were applied a diet compatible with the Mediterranean diet for 8 weeks.
Primary Outcome Measures
NameTimeMethod
Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzerBaseline, 8 weeks

RMR (kcal) was measured using the InBody 270 brand device.

Change in interleukin 6 (IL-6)Baseline, 8 weeks

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

Change in total antioxidant status (TAS)Baseline, 8 weeks

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

Change in fat-free mass measured by bioelectrical impedance analyzerBaseline, 8 weeks

Fat-free mass (kg) was measured using the InBody 270 brand device.

Change in malondialdehyde (MDA)Baseline, 8 weeks

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

Change in body weightBaseline, 8 weeks

Body weight (kg) was measured using the InBody 270 brand device.

Change in body mass indexsBaseline, 8 weeks

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.

Change in tumor necrosis factor alpha (TNF-α)Baseline, 8 weeks

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

Change in total oxidant status (TOS)Baseline, 8 weeks

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

Change in fat mass measured by bioelectrical impedance analyzerBaseline, 8 weeks

Fat mass (kg) was measured using the InBody 270 brand device.

Secondary Outcome Measures
NameTimeMethod
Change in oxidative stress index (OSI)Baseline, 8 weeks

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.

Change in waist circumferenceBaseline, 8 weeks

Waist circumference (cm) was measured with a non-stretch tape measure.

Change in hip circumferenceBaseline, 8 weeks

Hip circumference (cm) was measured with a non-stretch tape measure.

Change in dietary inflammatory index (DII)Baseline, 8 weeks

Dietary inflammatory index (DII) was calculated with 3-day food consumption record.

Trial Locations

Locations (1)

Aydın Adnan Menderes University, Faculty of Health Sciences, Department of Nutrition and Dietetics

🇹🇷

Aydın, Efeler, Turkey

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