Colorectal CancerNCT06018077
Chemerin in Colorectal Cancer and Its Relationship With Diet Quality
An observational study of Colorectal Cancer and Diet, Healthy, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Diet, Healthy, Diet Habit
- What is being tested?
- Dietary İntake, Biochemical parameters, Antropometric measuruments
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 104 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 31 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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),
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- 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
Trial locations and contacts
2 sites in 1 country.
Aylin Acikgoz Pinar contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Hacettepe University Health Science Faculty, Nutrition and Dietetic Department
Ankara, 06280
Semra Bakir Angay, +90 312 305 10 94 ext. 151, semrabakir@hacettepe.edu.tr
Aylin Acikgoz Pinar, PhD, +90 312 305 10 94 ext. 127, aylinn@hacettepe.edu.tr
- Recruiting
Ankara Bilkent City Hospital, Oncology Hospital, Medical Oncology Outpatient Clinic
Ankara, 06800
Mehmet Ali Nahit Sendur, Prof, +90 312 552 60 00
Semra Bakir Angay, +90 312 305 10 94 ext. 151
About this study
Official title: Investıgatıon of The Relatıonshıps Between Serum Chemerın Levels, Dıet Qualıty, Inflammatory and Phytochemıcal Indıces in Adults wıth Colorectal Cancer
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.
Read the 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.
- Being tested
- Dietary İntake, Biochemical parameters, Antropometric measuruments
- Keywords
- Colorectal cancer, Dietary inflammatory index, Dietary phytochemical index, Chemerin, Dietary total antioxidant capacity
- Medical subject headings
- Colorectal Neoplasms, Feeding Behavior, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary İntake, Biochemical parameters, Antropometric measurumentsBehavioural
Also called Food Frequency Questionnaire and Dietary Record, Blood Sample, Antropometric measurements (body weight, height, body fat rate, muscle rate, resting metabolic rate)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Behavioral: Dietary İntake, Biochemical parameters, Antropometric measuruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start15 Oct 2022
- Primary completion15 Jun 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Semra Bakir Angay, Hacettepe University
- Investigators
- Semra Bakir Angay, Principal investigator, Hacettepe UniversityAylin Acikgoz Pinar, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018077
- Sponsor's protocol ID
- GO22/297
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investıgatıon of The Relatıonshıps Between Serum Chemerın Levels, Dıet Qualıty, Inflammatory and Phytochemıcal Indıces in Adults wıth Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06018077
- Acronym / sponsor ID
- GO22/297
- Keywords
- Colorectal cancer, Dietary inflammatory index, Dietary phytochemical index, Chemerin, Dietary total antioxidant capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Group | – | Behavioral: Dietary İntake, Biochemical parameters, Antropometric measurumentsIndividuals 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) |
| Healthy Group | – | Behavioral: Dietary İntake, Biochemical parameters, Antropometric measurumentsA healthy adult between the ages of 18-65 who has not been diagnosed with any malignant disease and consented to participate in the study. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary İntake, Biochemical parameters, Antropometric measurumentsAlso: Food Frequency Questionnaire and Dietary Record, Blood Sample, Antropometric measurements (body weight, height, body fat rate, muscle rate, resting metabolic rate)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. | Behavioural | Colorectal Cancer Group, Healthy Group |
Primary outcome
Serum chemerin level
Time frame: 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.
Body weight
Time frame: 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.
Body fat percentage
Time frame: 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.
Body muscle percentage
Time frame: 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.
Visseral fat level
Time frame: 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.
Serum albumin level
Time frame: 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.
Serum C-reaktive protein (CRP)
Time frame: 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.
Body Mass Index (BMI)
Time frame: 12 months
Body mass index (BMI) will be obtained by dividing the body weight (kg) by the square of the height in meters.
Resting Metabolic Rate (RMR)
Time frame: 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.
Dietary Phytochemical Index (DPI)
Time frame: 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.
Dietary Inflammatory Index (DII)
Time frame: 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.
Dİetary Total Antioxidant Capacity (DTAC)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aylin Acikgoz Pinar contact
Semra Bakir Angay principal investigator
Hacettepe University
Aylin Acikgoz Pinar principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Diet, Healthy, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semra Bakir Angay (+903123051094 ext. 151, semrabakir@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum chemerin level (time frame: 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.