Relationship Between Diet, Oxidative Stress and Inflammation in Ankylosing Spondylitis

February 23, 2021 updated by: Fatma Gül Yurdakul, Ankara City Hospital Bilkent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatient clinic patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Other: Observational study, not applicable
Observational study, not applicable
Patient group
Patients with Ankylosing Spondylitis
Other: Observational study, not applicable
Observational study, not applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Will be done only once on the first day after inclusion.
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.
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
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
Will be done only once on the first day after inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Fatma Gul Yurdakul, Assoc.Prof., Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TURKEY
  • Principal Investigator: Hatice Bodur, Prof., Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TURKEY
  • Principal Investigator: Evren Yasar, Prof, Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TURKEY
  • Principal Investigator: Nilgun Seremet Kurklu, Asist.Prof., Akdeniz University, Faculty of Health Sciences, Department of Nutrition and Dietetics
  • Principal Investigator: Kubra Tel Adiguzel, Asist.Prof., University of Health Sciences Turkey, Gulhane Faculty of Health Sciences, Nutrition and Dietetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2020

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

February 3, 2021

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (ACTUAL)

February 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-20-938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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