Investigation of Oxidative Markers and Antioxidant Defense in Female Patients With Osteoarthritis

• Conditions: Osteoarthritis
• Interventions: Other: Questionnaire of eating habits

• Registration Number: NCT04206462
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Brief Summary

Osteoarthritis has a multifactorial etiology: aging, genetic, sex, weight, alimentation, injuries, infections etc. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the oxidative-antioxidative balance will be evaluated by determining markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde.

Detailed Description

A total of 300 patients with osteoarthritis will be included in the study. The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). Also, the weight and height of each patient will be assessed and the patients will be included in 4 classes based on the body mass index: underweight, normal weight, overweight and obese. The type of physical activity will also be noted and the oxidative-antioxidative balance will be evaluated by determining serum markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde. Correlation between eating behaviour, body mass index and oxidative stress markers will be made.

Study Timeline

• Study Start: 2019-07-17
• Status Verified: 2019-12
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-24
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• osteoarthritis
• signed informed consent

Exclusion Criteria

• drugs or foods with antioxidant effects
• lack of judgement
• refuse to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteoarthritis	Questionnaire of eating habits	Questionnaire of eating habits, markers of oxidative stress

Primary Outcome Measures

Name	Time	Method
serum concentration of oxidative stress markers	baseline	oxidated glutathione/reduced glutathion, catalase enzyme, superoxide dismutase, glutathion peroxidase, malonyldialdehyde

Trial Locations

Locations (1)

Clinical Rehabilitation Hospital; 🇷🇴 Cluj Napoca, Romania