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临床试验/NCT04818996
NCT04818996
已完成
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Evaluation of the Effect of Mediterranean Diet on Body Composition, Oxidant Stress and Proinflammatory Markers in Breast Cancer Patients

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 25 人2019年10月22日
适应症Breast Cancer

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Breast Cancer
发起方
Aydin Adnan Menderes University
入组人数
25
试验地点
1
主要终点
Change in resting metabolic rate (RMR) measured by bioelectrical impedance analyzer
状态
已完成
最后更新
5年前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2019年10月22日
结束日期
2021年1月20日
最后更新
5年前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

发起方
Aydin Adnan Menderes University
责任方
Principal Investigator
主要研究者

Burcu Deniz Gunes

Research Assistant

Aydin Adnan Menderes University

入排标准

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Baseline, 8 weeks

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

Change in interleukin 6 (IL-6)

时间窗: 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)

时间窗: 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 analyzer

时间窗: Baseline, 8 weeks

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

Change in malondialdehyde (MDA)

时间窗: 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 weight

时间窗: Baseline, 8 weeks

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

Change in body mass indexs

时间窗: 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.

Change in tumor necrosis factor alpha (TNF-α)

时间窗: 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)

时间窗: 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 analyzer

时间窗: Baseline, 8 weeks

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

次要结局

  • Change in oxidative stress index (OSI)(Baseline, 8 weeks)
  • Change in waist circumference(Baseline, 8 weeks)
  • Change in hip circumference(Baseline, 8 weeks)
  • Change in dietary inflammatory index (DII)(Baseline, 8 weeks)

研究点 (1)

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