Relationship Between Diet, Oxidative Stress and Inflammation in Ankylosing Spondylitis

NCT04772976 | Completed

• 1 other identifier: E1-20-938
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; Antioxidant capacity; Diet; Phytochemical index; Oxidant capacity

Outcome Measures

Primary Outcomes (3)

• Dietary phytochemical index

  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

  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

  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.

Study Arms (2)

Patient group

Patients with Ankylosing Spondylitis

Other: Observational study, not applicable

Healthy controls

Healthy controls

Other: Observational study, not applicable

Interventions

Observational study, not applicable OTHER

Observational study, not applicable

Healthy controls; Patient group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatient clinic patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 19327250 BACKGROUND

• 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.

  PMID: 17443328 BACKGROUND

• 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.

  PMID: 25252018 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Observation

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 26, 2021
• Study Start: November 16, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 3, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)