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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04206462
Other study ID # UniversitateaIH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2019
Est. completion date June 2020

Study information

Verified date December 2019
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact Rodica A Ungur, MD, PhD
Phone 0040507021
Email rodica.ana.ungur@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- osteoarthritis

- signed informed consent

Exclusion Criteria:

- drugs or foods with antioxidant effects

- lack of judgement

- refuse to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire of eating habits
frequency and type of aliments

Locations

Country Name City State
Romania Clinical Rehabilitation Hospital Cluj Napoca

Sponsors (1)

Lead Sponsor Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum concentration of oxidative stress markers oxidated glutathione/reduced glutathion, catalase enzyme, superoxide dismutase, glutathion peroxidase, malonyldialdehyde baseline
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