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Osteoarthritis, KneeNCT05214469

Evaluatıon of Nutrıtıonal Status and Total Antıoxıdant Capacıty in Osteoarthritis

An observational study of Osteoarthritis, Knee, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a descriptive cross-sectional study conducted to evaluate the nutritional status and total antioxidant/oxidant capacity of individuals diagnosed with osteoarthritis. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Knee
How many people
77 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2020to 1 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Outpatient clinic patients

Who may be able to join

  • Being between the ages of 18-65,
  • Being followed up with a diagnosis of knee-osteoarthritis by doctor

Who cannot join

  • Individuals under 18 and over 65 years of age,
  • Individuals with acute or chronic inflammatory diseases,
  • Individuals with chronic diseases,
  • Individuals who consume alcohol,
  • Smokers,
  • Individuals who have not taken additional vitamin and mineral supplements in the last 6 months,
  • Individualswho are not volunteer to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluatıon of Nutrıtıonal Status and Total Antıoxıdant Capacıty in Individuals Diagnosed of Osteoarthritis

This is a descriptive cross-sectional study conducted to evaluate the nutritional status and total antioxidant/oxidant capacity of individuals diagnosed with osteoarthritis.

Read the detailed description

The aim of this study is to determine the nutritional status of individuals diagnosed with osteoarthritis, to evaluate dietary total antioxidant/oxidant capacity and serum total antioxidant/oxidant capacity, and to examine the relationship of total antioxidant capacity with anthropometric measurements and nutritional status.

The study will include adult individuals diagnosed with osteoarthritis who applied to the Physical Therapy and Rehabilitation polyclinics of Ankara City Hospital. After the individuals fill out the questionnaire containing information about their socio-demographic characteristics, nutritional habits and physical activity levels, the researchers will take the food consumption records and the frequency of food consumption with a 24-hour reminder method. The total antioxidant amount of the diet will be determined from the food consumption records of the individuals. In addition to these, anthropometric measurements of individuals such as height, body weight and waist circumference will also be taken by the researchers.

In the study, routine biochemical parameter will be recorded from patient files and serum total antioxidant/oxidant capacity values will be examined.

The sample calculation was made using the Vanderbilt University Sample Calculation Tool, benefiting from the antioxidant capacity researches previously done in individuals with osteoarthritis in the literature. Assuming a standard deviation of ±20 in the study, the minimum sample size to be taken with 80% power and 5% error was determined as at least 47 people (case group) and 30 people (control group). In terms of the correct interpretation of the research results, the individuals in the case and control groups were similar in terms of age, gender and BMI in the selection of the sample (p≥0.05).

In the study, descriptive statistics (mean, lower value, upper value, standard deviation, standard deviation, mean) for data such as anthropometric measurements, daily consumption of food groups, energy and nutrient intakes, food consumption amounts and the rate of meeting the needs of energy and nutrients (%), number of meals. median) was calculated. The conformity of the variables to the normal distribution was examined using the Shapiro-Wilk test. Student's t test was used for the comparison of normally distributed variables in the groups (osteoarthritis diagnosis-control group), and the Mann-Whitney-U test was used for the comparison of non-normally distributed variables. In the comparison of more than two measurements, the Friedman test was used in cases where the normal distribution was not suitable. Correlations between numerical data were evaluated with the Pearson correlation test. The analyzes of the study were made in the SPSS 22.0 statistical package program and the statistical significance level was accepted as p<0.05.

Keywords
Osteoarthritis, Knee Osteoarthritis, Antioxidant Capacity, Oxidant Capacity, Nutrition
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05214469
Study groupRoleWhat they receive
Case GroupIndividuals diagnosed with knee-osteoarthritis
Control GroupIndividuals who do not have a chronic disease and are not diagnosed with osteoarthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Antioxidant and Oxidant Capacity

    Higher total antioxidant capacity is better and higher oxidant capacity is worse.

    Measured: 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.

  2. Dietary Total Antioxidant Capacity

    In order to evaluate the food consumption of the individuals, the food consumption frequency form (with their amounts) will also be applied. The dietary total antioxidant capacity (TAC) will be estimated using a FRAP (ferric reducing antioxidant potential).

    Measured: Will be obtained only once on the first day after inclusion.

Secondary outcomes (5)
  1. Osteoarthritis Stage

    Bilateral knee radiographs taken at the diagnosis stage will be interpreted by the doctor according to the Kellgren Lawrence staging system and osteoarthritis staging will be recorded. Osteoarthritis is deemed present at grade 2 although of minimal severity. Each radiograph will be assigned a grade from 0 to 4, which they correlated to increasing severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA.

    Measured: Will be obtained only once on the first day before inclusion.

  2. Physical Activity Status

    To determine the physical activity status of the participants. International Physical Activity Questionnaire-Short Form will be applied. Form will be applied and used to assess their physical condition. Higher score means more energy expended carrying out physical activity.

    Measured: Will be done obtained only once on the first day after inclusion.

  3. Height Measuring

    The height will be made with the height measuring tool of the scale.The head is level with a horizontal Frankfurt plane (below - an imaginary line from the lower border of the eye orbit to the auditory meatus).

    Measured: Will be done obtained only once on the first day after inclusion.

  4. Weight Measuring

    The body weights of the individuals participating in the research will be measured with a precision scale (±0.1 kg sensitive) that is calibrated at regular intervals, without shoes and wearing as light clothes as possible.

    Measured: Will be done obtained only once on the first day after inclusion.

  5. Body Mass Index (BMI)

    Body Mass Index (BMI), which is very important in the detection and evaluation of obesity or malnutrition; It will be calculated as kg/m² with the formula of body weight/height.

    Measured: Will be done obtained only once on the first day after inclusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start1 Jun 2020
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05214469
Sponsor's protocol ID
OSTEOBEDA
Status last verified
May 2022
First submitted
15 Dec 2021
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Knee, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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