Trial Title:
Chemerin in Colorectal Cancer and Its Relationship With Diet Quality
NCT ID:
NCT06018077
Condition:
Colorectal Cancer
Diet, Healthy
Diet Habit
Nutrition Aspect of Cancer
Inflammation
Conditions: Official terms:
Colorectal Neoplasms
Inflammation
Conditions: Keywords:
Colorectal cancer
Dietary inflammatory index
Dietary phytochemical index
Chemerin
Dietary total antioxidant capacity
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Behavioral
Intervention name:
Dietary İntake, Biochemical parameters, Antropometric measuruments
Description:
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.
Arm group label:
Colorectal Cancer Group
Arm group label:
Healthy Group
Other name:
Food Frequency Questionnaire and Dietary Record
Other name:
Blood Sample
Other name:
Antropometric measurements (body weight, height, body fat rate, muscle rate, resting metabolic rate)
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
19 Years
Maximum age:
64 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hacettepe University Health Science Faculty, Nutrition and Dietetic Department
Address:
City:
Ankara
Zip:
06280
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Semra Bakir Angay
Phone:
+90 312 305 10 94
Phone ext:
151
Email:
semrabakir@hacettepe.edu.tr
Contact backup:
Last name:
Aylin Acikgoz Pinar, PhD
Phone:
+90 312 305 10 94
Phone ext:
127
Email:
aylinn@hacettepe.edu.tr
Facility:
Name:
Ankara Bilkent City Hospital, Oncology Hospital, Medical Oncology Outpatient Clinic
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mehmet Ali Nahit Sendur, Prof
Phone:
+90 312 552 60 00
Contact backup:
Last name:
Semra Bakir Angay
Phone:
+90 312 305 10 94
Phone ext:
151
Start date:
October 15, 2022
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Hacettepe University
Agency class:
Other
Collaborator:
Agency:
Ankara Bilkent City Hospital
Agency class:
Other
Source:
Hacettepe University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06018077
