Clinical trial NCT06018077: Chemerin in Colorectal Cancer and Its Relationship With Diet Quality
Official title: Investıgatıon of The Relatıonshıps Between Serum Chemerın Levels, Dıet Qualıty, Inflammatory and Phytochemıcal Indıces in Adults wıth Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Diet, Healthy
Diet Habit
Nutrition Aspect of Cancer
Inflammation
Keywords: Colorectal cancer
Dietary inflammatory index
Dietary phytochemical index
Chemerin
Dietary total antioxidant capacity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2023-08-30
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After the necessary tests are made by the doctor of Ankara City Hospital Oncology Hospital Medical Oncology Polyclinic, individuals diagnosed as colorectal in the patient group, and those evaluated as healthy in the control group and meet the eligibility criteria will be included.

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.

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

Primary outcomes:
measure: Serum chemerin level
timeFrame: 12 months
measure: Body weight
timeFrame: 12 months
measure: Body fat percentage
timeFrame: 12 months
measure: Body muscle percentage
timeFrame: 12 months
measure: Visseral fat level
timeFrame: 12 months
measure: Serum albumin level
timeFrame: 12 months
measure: Serum C-reaktive protein (CRP)
timeFrame: 12 months
measure: Body Mass Index (BMI)
timeFrame: 12 months
measure: Resting Metabolic Rate (RMR)
timeFrame: 12 months
measure: Dietary Phytochemical Index (DPI)
timeFrame: 12 months
measure: Dietary Inflammatory Index (DII)
timeFrame: 12 months
measure: Dİetary Total Antioxidant Capacity (DTAC)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Health Science Faculty, Nutrition and Dietetic Department
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital, Oncology Hospital, Medical Oncology Outpatient Clinic
Study officials:
affiliation: Hacettepe University
name: Semra Bakir Angay
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Aylin Acikgoz Pinar
role: PRINCIPAL_INVESTIGATOR
References: