Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

NCT ID: NCT04818996

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-22
• Study Completion Date: 2021-01-20

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet

In the study, the participants were applied a diet compatible with the Mediterranean diet for 8 weeks.

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: BEHAVIORAL

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.

Interventions

Mediterranean Diet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

Burcu Deniz Gunes

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcu Deniz Güneş

Role: STUDY_CHAIR

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

Locations

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

Aydin, Efeler, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019/044

Identifier Type: -

Identifier Source: org_study_id