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Completed

NCT Number: NCT04818996

Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Aydin, Efeler, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean Diet

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.

Primary outcomes

  1. Change in body weight

    Time frame: Baseline, 8 weeks

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

  2. Change in body mass indexs

    Time frame: Baseline, 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.

  3. Change in fat mass measured by bioelectrical impedance analyzer

    Time frame: Baseline, 8 weeks

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

  4. Change in fat-free mass measured by bioelectrical impedance analyzer

    Time frame: Baseline, 8 weeks

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

  5. Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer

    Time frame: Baseline, 8 weeks

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

  6. Change in interleukin 6 (IL-6)

    Time frame: 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

  7. Change in tumor necrosis factor alpha (TNF-α)

    Time frame: 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

  8. Change in malondialdehyde (MDA)

    Time frame: 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

  9. Change in total antioxidant status (TAS)

    Time frame: 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

  10. Change in total oxidant status (TOS)

    Time frame: 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

Secondary outcomes

  1. Change in waist circumference

    Time frame: Baseline, 8 weeks

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

  2. Change in hip circumference

    Time frame: Baseline, 8 weeks

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

  3. Change in dietary inflammatory index (DII)

    Time frame: Baseline, 8 weeks

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

  4. Change in oxidative stress index (OSI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Mar 26, 2021
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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