Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05214469 |
| Other study ID # |
OSTEOBEDA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Akdeniz University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
