Ankylosing SpondylitisNCT04772976
Relationship Between Diet, Oxidative Stress and Inflammation in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Ankylosing Spondylitis (AS) is a chronic inflammatory autoimmune disease. The aim of this study is to reveal the relationship between dietary intake, blood total antioxidant capacity and disease activity in individuals with AS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Observational study, not applicable
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Nov 2020to 3 Feb 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient clinic patients
Who may be able to join
- Being between the ages of 18-65,
- Being followed up with a diagnosis of AS
Who cannot join
- Individuals under 18 and over 65 years of age,
- Those with active or previous history of malignancy
- Those diagnosed with cardiovascular disease
- Those with chronic kidney disease
- Those with liver disease
- Those with acute or chronic inflammatory diseases
Show all 14Show fewer
- Those with diabetes
- Those with acute or chronic infections
- Those who consume alcohol,
- Smokers,
- Pregnant and breastfeeding women,
- People with severe psychiatric illness,
- Those who take regular medication and antioxidant nutritional supplements,
- Those who are not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Dietary Phytochemical Index, Oxidative Stress and Inflammation of Patients With Ankylosing Spondylitis
Ankylosing Spondylitis (AS) is a chronic inflammatory autoimmune disease. The aim of this study is to reveal the relationship between dietary intake, blood total antioxidant capacity and disease activity in individuals with AS. This study will include patients diagnosed with AS who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and a control group that does not have AS. The sociodemographic characteristics and nutritional habits and 1-day physical activity status of individuals with AS and healthy persons will be recorded. Anthropometric measurements of all individuals (such as height length (cm) and body weight) will be taken. From the height and body weight measurements, the individuals body mass indexes will be calculated. All parts of the questionnaire for individuals included in the research will be filled in by the researcher through face-to-face interview technique. The disease activity score of the individuals in the case group will be evaluated by the physician. Serum biochemical parameters will be taken from the patient files. In the patient information system of the control group, above mentioned blood tests will be recorded from the examinations performed in the last 1 month. Serum total antioxidant and oxidant levels will be measured in a private laboratory with a tube (5 ml) of blood from all individuals. The parameters to be examined in blood samples are specific to the study and their cost will be covered by the researchers.
Read the detailed description
Ankylosing Spondylitis (AS) is a chronic inflammatory autoimmune disease that progresses with inflammation of synovial membranes. The aim of this study is to reveal the relationship between total dietary phytochemical intake, blood total antioxidant capacity and disease activity in individuals with AS. This study will include patients diagnosed with AS who applied to Ankara City Hospital Physical Medicine and Rehabilitation Hospital, and a control group that does not have AS and that meet exclusion criteria. The sociodemographic characteristics and nutritional habits, one-day food consumption records and 1-day physical activity status of AS diagnosed and healthy individuals included in the study will be recorded with a questionnaire. Anthropometric measurements of all individuals (case and control) such as height length (cm) and body weight (kg) will be taken. From the height and body weight measurements, the students' body mass indexes will be calculated from the formula [weight (kg) / height (m²)]. Waist circumference; The perimeter passing through the middle of the distance between the lowest costa and crista iliaca superior will be measured by tape measure. All parts of the questionnaire for individuals included in the research will be filled in by the researcher through face-to-face interview technique. The disease activity score (ASDAS) of the individuals in the case group will be evaluated by the physician. Serum biochemical parameters (complete blood count, fasting blood sugar, liver function tests, urea, creatinine, lipid profile, erythrocyte sedimentation rate, c-reactive protein) will be taken from the patient files. In the patient information system of the control group, complete blood count, fasting blood sugar, liver function tests, urea, creatinine, lipid profile, erythrocyte sedimentation rate, and c-reactive protein levels will be recorded from the examinations performed in the last 1 month. Serum total antioxidant and oxidant levels will be measured in a private laboratory with a tube (5 ml) of blood from all individuals. After the blood samples are centrifuged, 0.5 ml will be separated into eppendorfs. Samples will be stored in a -80 degree refrigerator in the Physical Medicine and Rehabilitation Hospital. Total antioxidant and oxidant capacity measurement will be done in a private laboratory in Ankara in the form of service procurement by Erel method. Samples for total antioxidant and oxidant analysis will be sent to the relevant laboratories in dry ice. The parameters to be examined in blood samples are specific to the study and their cost will be covered by the researchers.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Observational study, not applicable
- Keywords
- Ankylosing Spondylitis, Antioxidant capacity, Diet, Phytochemical index, Oxidant capacity
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, not applicableOther
Observational study, not applicable
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients with Ankylosing Spondylitis Receives: Other: Observational study, not applicable | |
| Healthy controls | Healthy controls Receives: Other: Observational study, not applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary phytochemical index
Dietary phytochemical index is calculated from one day dietary record. Higher index is better.
Measured: Will be done only once on the first day after inclusion.
Total antioxidant and oxidant capacity
Higher total antioxidant capacity and lower oxidant capacity is better.
Measured: Blood samples will be obtained once on the first day after inclusion. Samples will be stored in -80 C medical refrigerator and analysis will be done after collection of all samples.
Ankylosing Spondylitis Disease Activity Score
Higher scores (>2.1) mean active disease. Lower scores (<1.3) mean inactive disease
Measured: Will be done only once on the first day after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start16 Nov 2020
- Primary completion31 Jan 2021
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gül Yurdakul, Ankara City Hospital Bilkent
- Investigators
- Fatma Gul Yurdakul, Assoc.Prof., Principal investigator, Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TurkeyHatice Bodur, Prof., Principal investigator, Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TurkeyEvren Yasar, Prof, Principal investigator, Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TurkeyNilgun Seremet Kurklu, Asist.Prof., Principal investigator, Akdeniz University, Faculty of Health Sciences, Department of Nutrition and DieteticsKubra Tel Adiguzel, Asist.Prof., Principal investigator, University of Health Sciences Turkey, Gulhane Faculty of Health Sciences, Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772976
- Sponsor's protocol ID
- E1-20-938
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feijoo M, Tunez I, Tasset I, Montilla P, Ruiz A, Collantes E. Infliximab reduces oxidative stress in ankylosing spondylitis. Clin Exp Rheumatol. 2009 Jan-Feb;27(1):167-8; author reply 168. No abstract available.
PubMed 19327250Karakoc M, Altindag O, Keles H, Soran N, Selek S. Serum oxidative-antioxidative status in patients with ankylosing spondilitis. Rheumatol Int. 2007 Oct;27(12):1131-4. doi: 10.1007/s00296-007-0352-3. Epub 2007 Apr 19.
PubMed 17443328Howes MJ, Simmonds MS. The role of phytochemicals as micronutrients in health and disease. Curr Opin Clin Nutr Metab Care. 2014 Nov;17(6):558-66. doi: 10.1097/MCO.0000000000000115.
PubMed 25252018
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Dietary Phytochemical Index, Oxidative Stress and Inflammation of Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04772976
- Acronym / sponsor ID
- E1-20-938
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Antioxidant capacity, Diet, Phytochemical index, Oxidant capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 26 Feb 2021 (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.
Ankylosing Spondylitis (AS) is a chronic inflammatory autoimmune disease. The aim of this study is to reveal the relationship between dietary intake, blood total antioxidant capacity and disease activity in individuals with AS. This study will include patients diagnosed with AS who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and a control group that does not have AS. The sociodemographic characteristics and nutritional habits and 1-day physical activity status of individuals with AS and healthy persons will be recorded. Anthropometric measurements of all individuals (such as height length (cm) and body weight) will be taken. From the height and body weight measurements, the individuals body mass indexes will be calculated. All parts of the questionnaire for individuals included in the research will be filled in by the researcher through face-to-face interview technique. The disease activity score of the individuals in the case group will be evaluated by the physician. Serum biochemical parameters will be taken from the patient files. In the patient information system of the control group, above mentioned blood tests will be recorded from the examinations performed in the last 1 month. Serum total antioxidant and oxidant levels will be measured in a private laboratory with a tube (5 ml) of blood from all individuals. The parameters to be examined in blood samples are specific to the study and their cost will be covered by the researchers.
Detailed description
Ankylosing Spondylitis (AS) is a chronic inflammatory autoimmune disease that progresses with inflammation of synovial membranes. The aim of this study is to reveal the relationship between total dietary phytochemical intake, blood total antioxidant capacity and disease activity in individuals with AS. This study will include patients diagnosed with AS who applied to Ankara City Hospital Physical Medicine and Rehabilitation Hospital, and a control group that does not have AS and that meet exclusion criteria. The sociodemographic characteristics and nutritional habits, one-day food consumption records and 1-day physical activity status of AS diagnosed and healthy individuals included in the study will be recorded with a questionnaire. Anthropometric measurements of all individuals (case and control) such as height length (cm) and body weight (kg) will be taken. From the height and body weight measurements, the students' body mass indexes will be calculated from the formula [weight (kg) / height (m²)]. Waist circumference; The perimeter passing through the middle of the distance between the lowest costa and crista iliaca superior will be measured by tape measure. All parts of the questionnaire for individuals included in the research will be filled in by the researcher through face-to-face interview technique. The disease activity score (ASDAS) of the individuals in the case group will be evaluated by the physician. Serum biochemical parameters (complete blood count, fasting blood sugar, liver function tests, urea, creatinine, lipid profile, erythrocyte sedimentation rate, c-reactive protein) will be taken from the patient files. In the patient information system of the control group, complete blood count, fasting blood sugar, liver function tests, urea, creatinine, lipid profile, erythrocyte sedimentation rate, and c-reactive protein levels will be recorded from the examinations performed in the last 1 month. Serum total antioxidant and oxidant levels will be measured in a private laboratory with a tube (5 ml) of blood from all individuals. After the blood samples are centrifuged, 0.5 ml will be separated into eppendorfs. Samples will be stored in a -80 degree refrigerator in the Physical Medicine and Rehabilitation Hospital. Total antioxidant and oxidant capacity measurement will be done in a private laboratory in Ankara in the form of service procurement by Erel method. Samples for total antioxidant and oxidant analysis will be sent to the relevant laboratories in dry ice. The parameters to be examined in blood samples are specific to the study and their cost will be covered by the researchers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: Observational study, not applicablePatients with Ankylosing Spondylitis |
| Healthy controls | – | Other: Observational study, not applicableHealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic patients
Key inclusion criteria (2 listed)
- Being between the ages of 18-65,
- Being followed up with a diagnosis of AS
Key exclusion criteria (14 listed)
- Individuals under 18 and over 65 years of age,
- Those with active or previous history of malignancy
- Those diagnosed with cardiovascular disease
- Those with chronic kidney disease
- Those with liver disease
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 |
|---|---|---|
| Observational study, not applicableObservational study, not applicable | Other | Healthy controls, Patient group |
Primary outcome
Dietary phytochemical index
Time frame: Will be done only once on the first day after inclusion.
Dietary phytochemical index is calculated from one day dietary record. Higher index is better.
Total antioxidant and oxidant capacity
Time frame: Blood samples will be obtained once on the first day after inclusion. Samples will be stored in -80 C medical refrigerator and analysis will be done after collection of all samples.
Higher total antioxidant capacity and lower oxidant capacity is better.
Ankylosing Spondylitis Disease Activity Score
Time frame: Will be done only once on the first day after inclusion.
Higher scores (>2.1) mean active disease. Lower scores (<1.3) mean inactive disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 19327250Feijoo M, Tunez I, Tasset I, Montilla P, Ruiz A, Collantes E. Infliximab reduces oxidative stress in ankylosing spondylitis. Clin Exp Rheumatol. 2009 Jan-Feb;27(1):167-8; author reply 168. No abstract available.
- Background: PubMed 17443328Karakoc M, Altindag O, Keles H, Soran N, Selek S. Serum oxidative-antioxidative status in patients with ankylosing spondilitis. Rheumatol Int. 2007 Oct;27(12):1131-4. doi: 10.1007/s00296-007-0352-3. Epub 2007 Apr 19.
- Background: PubMed 25252018Howes MJ, Simmonds MS. The role of phytochemicals as micronutrients in health and disease. Curr Opin Clin Nutr Metab Care. 2014 Nov;17(6):558-66. doi: 10.1097/MCO.0000000000000115.
- Individual participant dataSharing planned: No
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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.
Fatma Gul Yurdakul, Assoc.Prof. principal investigator
Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, Turkey
Hatice Bodur, Prof. principal investigator
Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, Turkey
Evren Yasar, Prof principal investigator
Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Ankara City Hospital Bilkent at 1 site 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 2 inclusion and 14 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: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary phytochemical index (time frame: Will be done only once on the first day after inclusion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772976, which also lists 3 linked publications.
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 26 Feb 2021.