Chemerin in Colorectal Cancer and Its Relationship With Diet Quality

NCT06018077 | Unknown

• 1 other identifier: GO22/297
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Dİetary 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

Study Arms (2)

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

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

Interventions

Dietary İntake, Biochemical parameters, Antropometric measuruments 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.

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

Colorectal Cancer Group; Healthy Group

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.),

Sponsors & Collaborators

• Hacettepe University: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (2)

Hacettepe University Health Science Faculty, Nutrition and Dietetic Department

Ankara, 06280, Turkey (Türkiye)

RECRUITING

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

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1 tube of blood sample is centrifuged and serum is taken.

MeSH Terms

Conditions

Colorectal Neoplasms; Feeding Behavior; Inflammation

Interventions

Eating; Diet Records; Blood Specimen Collection; Weights and Measures; Body Height; Basal Metabolism

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior, Animal; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Records; Organization and Administration; Health Services Administration; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Physical Appearance, Body; Anthropometry; Growth; Growth and Development; Energy Metabolism; Metabolism

Study Officials

• Semra Bakir Angay

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Aylin Acikgoz Pinar

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Semra Bakir Angay

CONTACT

+903123051094; semrabakir@hacettepe.edu.tr

Aylin Acikgoz Pinar

CONTACT

903123051094

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: October 15, 2022
• Primary Completion: June 15, 2024
• Study Completion: August 31, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

TU (2)