Chemerin in Colorectal Cancer and Its Relationship With Diet Quality

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06018077
Collaborator
Ankara Bilkent City Hospital (Other)
104
2
34.5
52
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dietary İntake, Biochemical parameters, Antropometric measuruments

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
104 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Investıgatıon of The Relatıonshıps Between Serum Chemerın Levels, Dıet Qualıty, Inflammatory and Phytochemıcal Indıces in Adults wıth Colorectal Cancer
Actual Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2024
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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)

Behavioral: 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.
Other Names:
  • Food Frequency Questionnaire and Dietary Record
  • Blood Sample
  • Antropometric measurements (body weight, height, body fat rate, muscle rate, resting metabolic rate)
  • 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.

    Behavioral: 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.
    Other Names:
  • Food Frequency Questionnaire and Dietary Record
  • Blood Sample
  • Antropometric measurements (body weight, height, body fat rate, muscle rate, resting metabolic rate)
  • Outcome Measures

    Primary Outcome Measures

    1. Serum chemerin level [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.

    2. Body weight [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.

    3. Body fat percentage [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.

    4. Body muscle percentage [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.

    5. Visseral fat level [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.

    6. Serum albumin level [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.

    7. Serum C-reaktive protein (CRP) [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.

    8. Body Mass Index (BMI) [12 months]

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

    9. Resting Metabolic Rate (RMR) [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.

    10. Dietary Phytochemical Index (DPI) [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.

    11. Dietary Inflammatory Index (DII) [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.

    12. Dİetary Total Antioxidant Capacity (DTAC) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University Health Science Faculty, Nutrition and Dietetic Department Ankara Turkey 06280
    2 Ankara Bilkent City Hospital, Oncology Hospital, Medical Oncology Outpatient Clinic Ankara Turkey 06800

    Sponsors and Collaborators

    • Hacettepe University
    • Ankara Bilkent City Hospital

    Investigators

    • Principal Investigator: Semra Bakir Angay, Hacettepe University
    • Principal Investigator: Aylin Acikgoz Pinar, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Semra Bakir Angay, Principal Investigator, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT06018077
    Other Study ID Numbers:
    • GO22/297
    First Posted:
    Aug 30, 2023
    Last Update Posted:
    Aug 30, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Semra Bakir Angay, Principal Investigator, Hacettepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 30, 2023