跳至主要内容
临床试验/NCT06018077
NCT06018077招募中不适用

Investıgatıon of The Relatıonshıps Between Serum Chemerın Levels, Dıet Qualıty, Inflammatory and Phytochemıcal Indıces in Adults wıth Colorectal Cancer

Hacettepe University2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
104
试验地点
2
主要终点
Serum chemerin level

研究概览

简要总结

To investigate the relationship between serum chemerin levels of individuals with colorectal cancer and systematic inflammatory response parameters such as C-reactive protein(CRP) and albumin, and to investigate the relationship of these biomarkers with dietary inflammatory index, phytochemical, anthropometric measurements, and dietary inflammatory index, which is calculated with the data obtained from the 24-hour food consumption record and food consumption frequency questionnaire. The aim of this study is to examine the relationships between the index and dietary antioxidant capacity and to compare them with those of healthy individuals.

详细描述

The research will be executed. with 52 adult individuals between the ages of 18-65 who applied to the Ankara City Hospital Oncology Hospital Medical Oncology outpatient clinic, newly diagnosed with colorectal cancer (except for Stage IV), and 52 healthy adult individuals without any chronic disease, matched for age, gender, and BMI. Individuals will be told about the study in detail and those who accept will be included in the study by signing an informed consent form. A data collection form containing health and demographic information will be applied to the participants; Then, after 8-12 hours of fasting, body composition analysis (body fat ratio, muscle ratio, visceral fat level, resting metabolic rate) will be performed with the Omron BF511, a body composition analysis scale that works with the bioelectrical impedance method, and within the scope of anthropometric measurements, body weight, height length, BMI measurements will be taken. Body mass index (BMI) will be obtained by dividing the body weight (kg) by the square of the height in meters. After 8-12 hours of fasting, 5 ml of venous blood will be taken from the participants by the nurses of the Medical Oncology Clinic, and the serum obtained after centrifugation will be analyzed in accordance with the manufacturer's kit protocols and in duplicate, the C-reactive protein (CRP) level will be analyzed by the immunoturbidimetric method and the albumin Bromocresol Green-Dye binding method, and chemerin level by enzyme-linked immunoassay (ELISA) method. Nutritional status of individuals will be evaluated with a 24-hour retrospective food consumption record and food consumption frequency questionnaire, and dietary inflammatory index, phytochemical index, and dietary antioxidant capacity will be calculated from the obtained records. In order to measure the inflammatory potential of the diet, the Dietary Inflammatory Index (DII) was developed based on the pro-inflammatory and anti-inflammatory effects of different dietary components on various inflammatory biomarkers. The "Phytochemical Index" method was used to calculate the total phytochemical intake from the diet. The total antioxidant capacity of the diet was calculated using data obtained from dietary intake records based on Ferric Reducing Ability of Plasma (FRAP) methods.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For patient group
  • Between the ages of 18-65,
  • At least 3 weeks after surgery
  • Individuals newly diagnosed with colorectal cancer by a oncolog (except for Stage IV)
  • For healthy group
  • Between the ages of 18-65,
  • Healthy adult individuals without any chronic disease

排除标准

  • For patient group
  • Receiving active radiotherapy or chemotherapy,
  • Existing history of metastasis,
  • Having a malignant disease other than the diagnosis of colorectal cancer, - History of metabolic syndrome, cardiovascular disease, hepatic disease, chronic kidney disease, major hormonal or hematological disease, pulmonary disease,
  • With a history of autoimmune disease, with a history of inflammatory diseases (pancreatitis, chron's, ulcerative colitis, etc.),
  • Those who use nonsteroidal anti-inflammatory drugs (NSAIDs),
  • Alcoholic and other drug addicts,
  • Those with mental disorders (major depressive disorder, dementia),
  • Those who take corticosteroid or hormone therapy,
  • Those who have an existing infectious disease, those who receive medical nutrition therapy for any disease
  • For healthy group
  • Individuals aged 18 and under and 65 years and older,
  • History of metabolic syndrome, cardiovascular disease, hepatic disease, chronic kidney disease, major hormonal or hematological disease, pulmonary disease,
  • With a history of autoimmune disease, with a history of inflammatory diseases (pancreatitis, chron's, ulcerative colitis, etc.),
  • Those who use nonsteroidal anti-inflammatory drugs (NSAIDs),
  • Pregnant and lactating women,
  • Alcoholic and other drug addicts,
  • Smokers, those with mental disorders (major depressive disorder, dementia),
  • Those taking corticosteroid or hormone therapy,
  • Those with existing infectious disease,
  • Those receiving medical nutrition therapy for any illness

结局指标

主要结局

Serum chemerin level

时间窗: 12 months

The blood obtained from individuals after 8-12 hours of fasting will be analyzed in duplicate with the enzyme-linked immunity test (ELISA) method from the serum obtained after centrifugation, in accordance with the manufacturer's kit protocols.

Body Mass Index (BMI)

时间窗: 12 months

Body mass index (BMI) will be obtained by dividing the body weight (kg) by the square of the height in meters.

Body weight

时间窗: 12 months

The body weights of the individuals will be measured after 8-12 hours of fasting, using Omron BF511 brand bioelectrical impedance device, wearing light clothes without metal objects.

Body fat percentage

时间窗: 12 months

The body fat percentage of the individuals will be measured after 8-12 hours of fasting, using Omron BF511 brand bioelectrical impedance device, wearing light clothes without metal objects.

Body muscle percentage

时间窗: 12 months

The body muscle percentage of the individuals will be measured after 8-12 hours of fasting, using Omron BF511 brand bioelectrical impedance device, wearing light clothes without metal objects.

Visseral fat level

时间窗: 12 months

The visseral fat level of the individuals will be measured by using Omron BF511 brand bioelectrical impedance device while they are on an empty stomach and wearing light clothes without metal objects.

Serum albumin level

时间窗: 12 months

The blood obtained from individuals after 8-12 hours of fasting will be analyzed from the serum obtained after centrifugation, in duplicate using the Bromocresol Green-Dye binding method, in accordance with the manufacturer's kit protocols.

Dietary Inflammatory Index (DII)

时间窗: 12 months

The frequency of food consumption from the participants and the data to be obtained from the twenty-four hour retrospective food consumption record will be evaluated using the Computer Aided Nutrition Program Nutrition Information System (BeBIS 9.0). "Diet inflammatory index" will be calculated by multiplying the nutritional parameters obtained from the recordings with the "inflammatory effect score".The resulting values are summed to obtain the dietary inflammatory index (DII) score, which represents the inflammatory load of the individual's daily diet.

Serum C-reaktive protein (CRP)

时间窗: 12 months

The blood obtained from individuals after 8-12 hours of fasting will be analyzed in duplicate with the immunoturbidimetric method from the serum obtained after centrifugation, in accordance with the manufacturer's kit protocols.

Dİetary Total Antioxidant Capacity (DTAC)

时间窗: 12 months

Dietary total antioxidant capacity will be determined using the 'Antioxidant Food Database'. The FRAP value of that food will be calculated by multiplying the reported iron reducing antioxidant power (FRAP) value for each food and the grams of the daily average consumed food. The total antioxidant capacity (TAK) of the diet will be calculated by summing the calculated FRAP values of all foods and expressed as mmol/100 g nutrient.

Resting Metabolic Rate (RMR)

时间窗: 12 months

The resting metabolic rate of the individuals will be measured by using Omron BF511 brand bioelectrical impedance device while they are on an empty stomach and wearing light clothes without metal objects.

Dietary Phytochemical Index (DPI)

时间窗: 12 months

he "Phytochemical Index" method was used to calculate the total phytochemical intake from the diet. The ratio of the total amount of phytochemical rich foods in the diet in grams per day to the total food intake (g/day) will be calculated as follows. The amount of phytochemicals contained in each food will be obtained from the USDA database.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Semra Bakir Angay

Principal Investigator

Hacettepe University

研究点 (2)

Loading locations...

相似试验