Chemerin in Colorectal Cancer and Its Relationship With Diet Quality

NCT ID: NCT06018077

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2025-08-31

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer; Diet, Healthy; Diet Habit; Nutrition Aspect of Cancer; Inflammation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Colorectal Cancer Group

Individuals aged 18-65 years, who applied to Ankara City Hospital Oncology Hospital Medical Oncology Outpatient Clinic, newly diagnosed with colorectal cancer as a result of the necessary examinations, at least 3 weeks after the surgical procedure and without metastasis (except for Stage IV)

Dietary İntake, Biochemical parameters, Antropometric measuruments

Intervention Type: BEHAVIORAL

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.

Healthy Group

A healthy adult between the ages of 18-65 who has not been diagnosed with any malignant disease and consented to participate in the study.

Dietary İntake, Biochemical parameters, Antropometric measuruments

Intervention Type: BEHAVIORAL

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.

Interventions

Dietary İntake, 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Food Frequency Questionnaire and Dietary Record; Blood Sample; Antropometric measurements (body weight, height, body fat rate, muscle rate, resting metabolic rate)

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Semra Bakir Angay

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semra Bakir Angay

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Aylin Acikgoz Pinar

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University Health Science Faculty, Nutrition and Dietetic Department

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Ankara Bilkent City Hospital, Oncology Hospital, Medical Oncology Outpatient Clinic

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Semra Bakir Angay

Role: CONTACT

semrabakir@hacettepe.edu.tr

+903123051094 ext. 151

Aylin Acikgoz Pinar

Role: CONTACT

903123051094

Facility Contacts

Semra Bakir Angay

Role: primary

semrabakir@hacettepe.edu.tr

+90 312 305 10 94 ext. 151

Aylin Acikgoz Pinar, PhD

Role: backup

aylinn@hacettepe.edu.tr

+90 312 305 10 94 ext. 127

Mehmet Ali Nahit Sendur, Prof

Role: primary

+90 312 552 60 00

Semra Bakir Angay

Role: backup

+90 312 305 10 94 ext. 151

Other Identifiers

GO22/297

Identifier Type: -

Identifier Source: org_study_id