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Relationship Between Diet, Oxidative Stress and Inflammation in Ankylosing Spondylitis

NCT ID: NCT04772976

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-02-03

Brief Summary

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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

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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

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Ankylosing Spondylitis

Keywords

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Ankylosing Spondylitis Antioxidant capacity Diet Phytochemical index Oxidant capacity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient group

Patients with Ankylosing Spondylitis

Observational study, not applicable

Intervention Type OTHER

Observational study, not applicable

Healthy controls

Healthy controls

Observational study, not applicable

Intervention Type OTHER

Observational study, not applicable

Interventions

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Observational study, not applicable

Observational study, not applicable

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 18-65,
* Being followed up with a diagnosis of AS

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Fatma Gül Yurdakul

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Gul Yurdakul, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, Turkey

Hatice Bodur, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, Turkey

Evren Yasar, Prof

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, Turkey

Nilgun Seremet Kurklu, Asist.Prof.

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University, Faculty of Health Sciences, Department of Nutrition and Dietetics

Kubra Tel Adiguzel, Asist.Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences Turkey, Gulhane Faculty of Health Sciences, Nutrition and Dietetics

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19327250 (View on PubMed)

Karakoc 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.

Reference Type BACKGROUND
PMID: 17443328 (View on PubMed)

Howes 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.

Reference Type BACKGROUND
PMID: 25252018 (View on PubMed)

Other Identifiers

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E1-20-938

Identifier Type: -

Identifier Source: org_study_id