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).
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.
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.
- Conditions
- Osteoarthritis, Knee
- 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 group | Role | What they receive |
|---|---|---|
| Case Group | Individuals diagnosed with knee-osteoarthritis | |
| Control Group | Individuals 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.
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.
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)
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.
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.
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.
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.
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.
- First posted28 Jan 2022
- Study start1 Jun 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beda Büşra ÖZALP, Akdeniz University
- Investigators
- Nilgün SEREMET KÜRKLÜ, Asist. Prof., Study director, Akdeniz University, Faculty of Health Sciences, Nutrition and Dietetics, Antalya, TURKEYBeda ÖZALP, Dietetican, Principal investigator, Akdeniz University, Faculty of Health Sciences, Nutrition and Dietetics, Antalya, TurkeyEmre ADIGÜZEL, Assoc. Prof., Study chair, Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TURKEYKübra Tel Adıgüzel, Asist. Prof., Study chair, University of Health Sciences, Faculty of Health Sciences, Nutrition and Dietetics, Ankara, TURKEY
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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon of Nutrıtıonal Status and Total Antıoxıdant Capacıty in Individuals Diagnosed of Osteoarthritis
- ClinicalTrials.gov ID
- NCT05214469
- Acronym / sponsor ID
- OSTEOBEDA
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee Osteoarthritis, Antioxidant Capacity, Oxidant Capacity, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a descriptive cross-sectional study conducted to evaluate the nutritional status and total antioxidant/oxidant capacity of individuals diagnosed with osteoarthritis.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | –Individuals diagnosed with knee-osteoarthritis |
| Control Group | – | –Individuals who do not have a chronic disease and are not diagnosed with osteoarthritis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic patients
Key inclusion criteria (2 listed)
- Being between the ages of 18-65,
- Being followed up with a diagnosis of knee-osteoarthritis by doctor
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 is better and higher oxidant capacity is worse.
Dietary Total Antioxidant Capacity
Time frame: Will be obtained only once on the first day after inclusion.
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).
5 secondary outcomes
Osteoarthritis Stage
Time frame: Will be obtained only once on the first day before inclusion.
Physical Activity Status
Time frame: Will be done obtained only once on the first day after inclusion.
Height Measuring
Time frame: Will be done obtained only once on the first day after inclusion.
Weight Measuring
Time frame: Will be done obtained only once on the first day after inclusion.
Body Mass Index (BMI)
Time frame: Will be done obtained only once on the first day after inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilgün SEREMET KÜRKLÜ, Asist. Prof. study director
Akdeniz University, Faculty of Health Sciences, Nutrition and Dietetics, Antalya, TURKEY
Beda ÖZALP, Dietetican principal investigator
Akdeniz University, Faculty of Health Sciences, Nutrition and Dietetics, Antalya, Turkey
Emre ADIGÜZEL, Assoc. Prof. study chair
Ankara City Hospital, Physical Medicine and Rehabilitation Hospital, Ankara, TURKEY
1 site in 1 country: see every site and its status.
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.