Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818996
• Other study ID #: 2019/044
• Status: Completed
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: March 2021
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 20, 2021
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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-a, CRP, MDA, TAS, TOS and routine blood parameters) were evaluated.

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University, Faculty of Health Sciences, Department of Nutrition and Dietetics	Aydin	Efeler

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Body weight (kg) was measured using the InBody 270 brand device.	Baseline, 8 weeks
Primary	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
Primary	Change in fat mass measured by bioelectrical impedance analyzer	Fat mass (kg) was measured using the InBody 270 brand device.	Baseline, 8 weeks
Primary	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
Primary	Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer	RMR (kcal) was measured using the InBody 270 brand device.	Baseline, 8 weeks
Primary	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
Primary	Change in tumor necrosis factor alpha (TNF-a)	Blood was drawn from participants for assessment of TNF-a (pg/mL) at the beginning and end of the study after fasting for at least 8 hours	Baseline, 8 weeks
Primary	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
Primary	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
Primary	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	Change in waist circumference	Waist circumference (cm) was measured with a non-stretch tape measure.	Baseline, 8 weeks
Secondary	Change in hip circumference	Hip circumference (cm) was measured with a non-stretch tape measure.	Baseline, 8 weeks
Secondary	Change in dietary inflammatory index (DII)	Dietary inflammatory index (DII) was calculated with 3-day food consumption record.	Baseline, 8 weeks
Secondary	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