Chemerin in Colorectal Cancer and Its Relationship With Diet Quality

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018077
• Other study ID #: GO22/297
• Status: Recruiting
• Start date: October 15, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: Hacettepe University
• Contact: Semra Bakir Angay
• Phone: +903123051094
• Email: semrabakir[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: August 31, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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,

• Smokers,

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Diet Habit
• Diet, Healthy
• Inflammation
• Nutrition Aspect of Cancer

Intervention

Behavioral:
• Dietary Intake, Biochemical parameters, Antropometric measuruments
Nutritional status of individuals will be evaluated with a 24-hour retrospective food consumption record and food consumption frequency questionnaire. After 8-12 hours of fasting, body composition analysis will be performed and within the scope of anthropometric measurements, body weight, height length, BMI measurements will be taken. Then, venous blood will be taken from the participants C-reactive protein (CRP), albumin and chemerin level will be analyzed.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital, Oncology Hospital, Medical Oncology Outpatient Clinic	Ankara
Turkey	Hacettepe University Health Science Faculty, Nutrition and Dietetic Department	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Ankara Bilkent City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum chemerin level	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.	12 months
Primary	Body weight	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.	12 months
Primary	Body fat percentage	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.	12 months
Primary	Body muscle percentage	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.	12 months
Primary	Visseral fat level	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.	12 months
Primary	Serum albumin level	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.	12 months
Primary	Serum C-reaktive protein (CRP)	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.	12 months
Primary	Body Mass Index (BMI)	Body mass index (BMI) will be obtained by dividing the body weight (kg) by the square of the height in meters.	12 months
Primary	Resting Metabolic Rate (RMR)	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.	12 months
Primary	Dietary Phytochemical Index (DPI)	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.	12 months
Primary	Dietary Inflammatory Index (DII)	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.	12 months
Primary	DIetary Total Antioxidant Capacity (DTAC)	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.	12 months