Osteoarthritis, KneeKDSKOANCT06269549
Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis
A study testing Non-training Real Dietary Supplement (G1) and Training Real Dietary Supplement (G3) in people with Osteoarthritis, Knee, run by University of Primorska at 2 sites in Slovenia.
Trial summary
The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are: Is adding a dietary supplement to exercise additionally effective in managing KOA? Is adding exercise to the dietary supplement… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Non-training Real Dietary Supplement (G1) and Training Real Dietary Supplement (G3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesSlovenia
- Study dates
- 11 Mar 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee osteoarthritis of one or both knee
- severity of knee osteoarthritis based on Kellgren-Lawrence radiographic grade 1-3
- knee pain between 4 and 7 (using a 0-10 scale)
Who cannot join
- Age <55 years
- Kellgren \& Lawrence grade 4 of knee osteoarthritis
- Acute knee injuries within the last 6 months
- Knee pain not associated with knee osteoarthritis
- History of knee or hip endoprosthesis
- Surgery on the back, hip, knee, ankle, or foot within the last 12 months
Show all 17Show fewer
- Health issues or musculoskeletal limitations affecting strength training and mobility more than knee pain (e.g., lower back pain, hip pain)
- Rheumatoid arthritis, gout
- Neurological conditions (Alzheimer's disease, Parkinson's disease, metabolic diseases affecting the nervous system)
- Muscular or joint diseases/injuries affecting lower limb function (e.g., hip and/or ankle osteoarthritis, sprains, fractures)
- Internal medical conditions (cardiovascular, pulmonary, oncological, diabetes with late complications - diabetic foot, neuropathies) affecting physical performance
- Stroke or similar condition with consequences on motor skills and/or cognition (inability to provide consent)
- Balance disorders, known vestibular system impairment
- Body Mass Index > 32
- Structured strength training exceeding 30 minutes per week
- Corticosteroids and/or hyaluronic acid (intra-articular) use in the last 6 months
- Individuals taking joint health dietary supplements, like glucosamine, chondroitin, or collagen, will need to halt use for at least 30 days before measurements to avoid affecting study outcomes
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
University of Primorska, Faculty of Health Sciences
Izola, 6310
Community Healthcare Center dr. Adolf Drolc
Maribor, 2000
About this study
Official title: Effectiveness of Kinesiological and Dietary Supplement Intervention in Individuals With Knee Osteoarthritis
The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are:
- Is adding a dietary supplement to exercise additionally effective in managing KOA?
- Is adding exercise to the dietary supplement additionally effective in managing KOA?
Read more
Participants will be given in three groups:
- Real dietary supplement alone
- Real dietary supplement with exercise
- Placebo dietary supplement with exercise
Investigators will compare groups 1 and 2, or 2 and 3, to answer the research questions.
The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone.
Read the detailed description
Participant recruitment will take place at the Community Healthcare Center dr. Adolf Drolc Maribor based on the doctor's recommendation. Following an informed discussion about the study and potential risks, all patients providing written consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, participants who choose to join an exercise group will be randomly assigned in a 1:1 ratio to either dietary supplements combined with exercise, or placebo dietary supplement combined with exercise. Participants who choose not to participate in exercise will be assigned to the supplement-only grouo, which serves as non-randomized comparator.
The effects of the kinesiological / dietary supplement intervention on selected measures will be assessed using a test battery, before and after the 12 week intervention, and at a 6-week post intervention follow-up.
Exercise / test batery will be conducted at Community Healthcare Center dr. Adolf Drolc under the supervision of an experienced kinesiologist / investigator.
Based on the posed research questions and hypotheses, investigators would like to highlight the following planned statistical analyses. In the case of bilateral KOA, investigators will analyze the more affected knee for differences between groups. In addition to descriptive statistics, investigators will assess normal distribution and homogeneity of variances. Differences between groups will be tested using two-way repeated measures analysis of variance (factor 1 = group, factor 2 = time) and paired two-tailed post-hoc t-tests with Bonferroni correction. The main comparison will be addressed with a 2x2 two-way analysis of variance. The first research question will be addressed with a 2x2 two-way analysis of variance, including groups 2 and 3. The second research question will be addressed with a two-way analysis of variance, including groups 1 and 2. Additionally, effect size will be calculated. The level of statistical significance will be set at p<0.05.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Non-training Real Dietary Supplement (G1), Training Placebo Dietary Supplement (G2), Training Real Dietary Supplement (G3)
- Keywords
- exercise, physical activity, dietary supplement
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-training Real Dietary Supplement (G1)Other
One capsule of glucosamine three times daily, and one packet of hydrolyzed collagen.
Training Placebo Dietary Supplement (G2)Other
One capsule of placebo glucosamine three times daily, and one packet containing placebo collagen + physical exercise (60 minutes per session twice a week)
Training Real Dietary Supplement (G3)Other
One capsule of glucosamine three times daily, and one packet of hydrolyzed collagen + physical exercise (60 minutes per session twice a week)
| Study group | Role | What they receive |
|---|---|---|
| The effect of dietary supplements added to physical exercise intervention | Other | This study arm will include two groups of participants, one receiving 12 weeks physical exercise intervention together with real dietary supplements (glucosamne and collagen), while the other group receiving exercise intervention with placebo dietary supplements (placebo glucosamine and collagen). Receives: Other: Training Placebo Dietary Supplement (G2); Other: Training Real Dietary Supplement (G3) |
| The effect of physical exercise added to dietary supplement intervention | Other | This study arm will include two groups of participants, one receiving 12 weeks real dietary supplements alone (glucosamine and collagen), while the other group receiving real dietary supplements (glucosamine and collagen) with physical exercise. Receives: Other: Non-training Real Dietary Supplement (G1); Other: Training Real Dietary Supplement (G3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 and at a 6-week follow-up
WOMAC is a self-assessment questionnaire consisting of 24 questions, addressing pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A higher achieved value or sum of points (0-96) indicates a worse condition.
Measured: Baseline, week 12 and at a 6-week follow-up
Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12
SF-36 is a self-assessment questionnaire on quality of life consisting of 36 items, which are grouped into domains measuring eight health components: physical functioning, role limitations due to physical health, role limitations due to emotional health, vitality, mental health, social functioning, bodily pain, and general health. Each item is scored, and each health component provides a score ranging from 0 to 100, where a score of 0 indicates very poor health, while a score of 100 indicates excellent health.
Measured: Baseline and week 12
Change from baseline in knee pain on numeric rating scale at week 12
Numeric rating scale (NRS) measures pain intensity. It is subjectively assess the current level of knee pain on a scale from 0 (no pain) to 10 (worst possible pain). Change = week 12 score - baseline score
Measured: Baseline and week 12
Change from baseline in 40 metre fast-paced walk at week 12 and at a 6-week follow-up
A timed walk of 4 x 10 metres for a total of 40 metres
Measured: Baseline, week 12 and at a 6-week follow-up
Change from baseline in static balance time at week 12
A piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, allowing us to record the movement of the center of pressure on the surface over time. The position is a single-leg stance, with the test conducted with eyes open, and parallel stance with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate time of single-leg stance and parallel stance.
Measured: Baseline and week 12
Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12
The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific amplitude from the center of pressure on the surface.
Measured: Baseline and week 12
Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12
The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific velocity from the center of pressure on the surface.
Measured: Baseline and week 12
Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12
The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific frequency from the center of pressure on the surface.
Measured: Baseline and week 12
Change from baseline in number of repetitions in Chair Stand Test at week 12 and at a 6-week follow-up
Chair Stand Test is measure lower body strength, in which participants stand up repeatedly from a chair for 30 seconds with their arms across their chest. Investigators will measure the number of repetitions in one set.
Measured: Baseline, 12 week and at a 6-week follow-up
Change from baseline in time for Five Times Sit to Stand Test at week 12
The Five Times Sit to Stand Test scoring is based on the amount of time (to the nearest decimal in seconds) a participant is able to transfer from a seated to a standing position and back to sitting five times with their arms across their chest. Test is used to asses functional lower limbs strength, balance, and fall risk.
Measured: Baseline, 12 week and at a 6-week follow-up
Change from baseline in lower body flexibility at week 12
The participant sits on the edge of a chair. One foot must remain flat on the floor, while the other leg is extended forward with the knee straight, heel on the floor, and ankle bent at a 90° angle. One hand is placed on top of the other, with the middle fingers aligned. The participant reaches forward towards the toes by bending at the hips. The back remains straight. The final position is held for 2 seconds. Investigators measure the distance between the fingertips and the toes. Two trials are performed, and the better result is considered.
Measured: Baseline and 12 week
Change from baseline in Timed up-and-go test (TUG) at week 12 and at a 6-week follow-up
Timed up-and-go test measures functional mobility and balance. Participants will start seated in a chair with armrests. Upon the investigator's signal, participants will rise from the chair, walk 3 meters forward, turn around, walk back to the chair, and sit down. The time taken to complete the task will be recorded to the nearest tenth of a second. The test will be performed three times, and the best time will be recorded for analysis.
Measured: Baseline, week 12 and at 6-week follow-up
Change from baseline in 10-Step Stair Climb Test (SCT) at week 12 and at a 6-week follow-up
After the practice trial, participants will perform one test trial, during which they will be instructed to ascend and descend a flight of 10 stairs as quickly as possible while maintaining safety. The time taken to complete the task will be recorded to the nearest tenth of a second.
Measured: Baseline, week 12 and at 6-week follow-up
Change from baseline in 6-minute walk distance at week 12
6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome.
Measured: Baseline and 12 week
Change from baseline in maximal isometric voluntary contraction of knee flexors and extensors at week 12
Maximal isometric voluntary contraction of knee flexion and extension will be performed using a knee dynamometer (S2P, Science in Practice, Ltd., Ljubljana, Slovenia), which will allow knee flexion and extension under static conditions with a knee joint angle of 60° and hip flexion in a seated position at 90°. A support will be placed over the ankle (2-3 cm above the lateral malleolus), through which the participant will press against the measuring part of the device. Before the measurement, the participant will perform two repetitions of flexion and extension with submaximal force, aimed at warming up the participant and familiarizing them with the test requirements. This will be followed by 3 muscle contractions with a 3-second hold at the maximum force produced, during which the participant will be verbally encouraged to achieve maximum strength.
Measured: Baseline and week 12
Secondary outcomes (6)
Change from baseline in presence of inflammatory markers in blood sample at week 12
Blood sample analysis for the presence of inflammatory markers (CRP, TNF-α, IL-6, IL-1β)
Measured: Baseline and week 12
Change from baseline in 24-hour time use at week 12
Assess 24-hour time use with activPAL sensors (sleep, wakefulness, sedentary behavior, physical activity).
Measured: Baseline and 12 week
Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12
DAB-Q questionnaire for recalling a seven-day period of time use. It assesses the time spent sleeping, awake/sedentary, and engaging in physical activity within the context of 24-hour time use.
Measured: Baseline and week 12
Change from baseline in handgrip strength at week 12
Handgrip strength will be measured using a hand hydraulic dynamometer. Participants will sit with their elbow flexed at 90° and squeeze the device handle as hard as possible for three seconds. Three repeated measurements will be taken from the dominant hand, and the maximum value (in kilograms) will be recorded.
Measured: Baseline and week 12
Change from baseline in number of repetitions in Arm Curl Test at week 12
An arm curl test assess upper body strength. The test involves sitting in a chair holding a weight with the palm facing the body. The arm should be against the trunk to avoid using other muscle groups. As the arm is brought through the range of motion, the wrist should rotate ending up facing the participant (supination). The number of repetitions (as many curls) in 30 seconds is used as the outcome.
Measured: Baseline and 12 week
Change from baseline in upper body flexibility at week 12
The Back Scratch Test measures how close the hands can be brought together behind the back. This test is done in the standing position. Investigators measure the distance between the tips of the middle fingers. Two trials are performed, and the better result is considered.
Measured: Baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start11 Mar 2024
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Community Healthcare Center dr. Adolf Drolc Maribor (HCM)
- Responsible party
- Principal investigator, Nejc Sarabon, University of Primorska
- Investigators
- Nejc Šarabon, PhD, Study chair, University of Primorska, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269549
- Sponsor's protocol ID
- KDS_KOA
- Acronym
- KDSKOA
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ceh T, Zavrsnik J, Sarabon N. Complementary effect of a combined exercise and dietary supplement intervention in individuals with knee osteoarthritis: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2026 Mar 3;27(1):274. doi: 10.1186/s13063-026-09594-7.
PubMed 41772729Ceh T, Zavrsnik J, Sarabon N, Prosen M. Experiences and perceptions of a 12-week combined exercise and dietary supplement program for individuals with knee osteoarthritis: a qualitative focus group study. BMC Musculoskelet Disord. 2026 Jan 20;27(1):145. doi: 10.1186/s12891-026-09509-2.
PubMed 41559644
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesiological and Dietary Supplement Intervention in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06269549
- Acronym / sponsor ID
- KDSKOA / KDS_KOA
- Conditions
- Osteoarthritis, Knee
- Keywords
- exercise, physical activity, dietary supplement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Community Healthcare Center dr. Adolf Drolc Maribor (HCM)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Feb 2024 (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.
The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are:
- Is adding a dietary supplement to exercise additionally effective in managing KOA?
- Is adding exercise to the dietary supplement additionally effective in managing KOA?
Participants will be given in three groups:
- Real dietary supplement alone
- Real dietary supplement with exercise
- Placebo dietary supplement with exercise
Investigators will compare groups 1 and 2, or 2 and 3, to answer the research questions.
The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone.
Detailed description
Participant recruitment will take place at the Community Healthcare Center dr. Adolf Drolc Maribor based on the doctor's recommendation. Following an informed discussion about the study and potential risks, all patients providing written consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, participants who choose to join an exercise group will be randomly assigned in a 1:1 ratio to either dietary supplements combined with exercise, or placebo dietary supplement combined with exercise. Participants who choose not to participate in exercise will be assigned to the supplement-only grouo, which serves as non-randomized comparator.
The effects of the kinesiological / dietary supplement intervention on selected measures will be assessed using a test battery, before and after the 12 week intervention, and at a 6-week post intervention follow-up.
Exercise / test batery will be conducted at Community Healthcare Center dr. Adolf Drolc under the supervision of an experienced kinesiologist / investigator.
Based on the posed research questions and hypotheses, investigators would like to highlight the following planned statistical analyses. In the case of bilateral KOA, investigators will analyze the more affected knee for differences between groups. In addition to descriptive statistics, investigators will assess normal distribution and homogeneity of variances. Differences between groups will be tested using two-way repeated measures analysis of variance (factor 1 = group, factor 2 = time) and paired two-tailed post-hoc t-tests with Bonferroni correction. The main comparison will be addressed with a 2x2 two-way analysis of variance. The first research question will be addressed with a 2x2 two-way analysis of variance, including groups 2 and 3. The second research question will be addressed with a two-way analysis of variance, including groups 1 and 2. Additionally, effect size will be calculated. The level of statistical significance will be set at p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time)
| Arm | Type | Receives |
|---|---|---|
| The effect of dietary supplements added to physical exercise intervention | Other | Other: Training Placebo Dietary Supplement (G2), Other: Training Real Dietary Supplement (G3)This study arm will include two groups of participants, one receiving 12 weeks physical exercise intervention together with real dietary supplements (glucosamne and collagen), while the other group receiving exercise intervention with placebo dietary supplements (placebo glucosamine and collagen). |
| The effect of physical exercise added to dietary supplement intervention | Other | Other: Non-training Real Dietary Supplement (G1), Other: Training Real Dietary Supplement (G3)This study arm will include two groups of participants, one receiving 12 weeks real dietary supplements alone (glucosamine and collagen), while the other group receiving real dietary supplements (glucosamine and collagen) with physical exercise. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- knee osteoarthritis of one or both knee
- severity of knee osteoarthritis based on Kellgren-Lawrence radiographic grade 1-3
- knee pain between 4 and 7 (using a 0-10 scale)
Key exclusion criteria (17 listed)
- Age <55 years
- Kellgren \& Lawrence grade 4 of knee osteoarthritis
- Acute knee injuries within the last 6 months
- Knee pain not associated with knee osteoarthritis
- History of knee or hip endoprosthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-training Real Dietary Supplement (G1)One capsule of glucosamine three times daily, and one packet of hydrolyzed collagen. | Other | The effect of physical exercise added to dietary supplement intervention |
| Training Placebo Dietary Supplement (G2)One capsule of placebo glucosamine three times daily, and one packet containing placebo collagen + physical exercise (60 minutes per session twice a week) | Other | The effect of dietary supplements added to physical exercise intervention |
| Training Real Dietary Supplement (G3)One capsule of glucosamine three times daily, and one packet of hydrolyzed collagen + physical exercise (60 minutes per session twice a week) | Other | The effect of dietary supplements added to physical exercise intervention, The effect of physical exercise added to dietary supplement intervention |
Primary outcome
Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 and at a 6-week follow-up
Time frame: Baseline, week 12 and at a 6-week follow-up
WOMAC is a self-assessment questionnaire consisting of 24 questions, addressing pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A higher achieved value or sum of points (0-96) indicates a worse condition.
Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12
Time frame: Baseline and week 12
SF-36 is a self-assessment questionnaire on quality of life consisting of 36 items, which are grouped into domains measuring eight health components: physical functioning, role limitations due to physical health, role limitations due to emotional health, vitality, mental health, social functioning, bodily pain, and general health. Each item is scored, and each health component provides a score ranging from 0 to 100, where a score of 0 indicates very poor health, while a score of 100 indicates excellent health.
Change from baseline in knee pain on numeric rating scale at week 12
Time frame: Baseline and week 12
Numeric rating scale (NRS) measures pain intensity. It is subjectively assess the current level of knee pain on a scale from 0 (no pain) to 10 (worst possible pain). Change = week 12 score - baseline score
Change from baseline in 40 metre fast-paced walk at week 12 and at a 6-week follow-up
Time frame: Baseline, week 12 and at a 6-week follow-up
A timed walk of 4 x 10 metres for a total of 40 metres
Change from baseline in static balance time at week 12
Time frame: Baseline and week 12
A piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, allowing us to record the movement of the center of pressure on the surface over time. The position is a single-leg stance, with the test conducted with eyes open, and parallel stance with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate time of single-leg stance and parallel stance.
Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12
Time frame: Baseline and week 12
The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific amplitude from the center of pressure on the surface.
Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12
Time frame: Baseline and week 12
The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific velocity from the center of pressure on the surface.
Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12
Time frame: Baseline and week 12
The position is a single-leg stance and parallel stance on piezoelectric force plate (Kistler, Winterthur, Switzerland, model 9260AA) for a measure forces on the surface, with the test conducted with eyes open and eyes closed, with three 30-second repetitions in each position. In evaluating the quality of static balance performance, investigators will calculate overall and direction-specific frequency from the center of pressure on the surface.
Change from baseline in number of repetitions in Chair Stand Test at week 12 and at a 6-week follow-up
Time frame: Baseline, 12 week and at a 6-week follow-up
Chair Stand Test is measure lower body strength, in which participants stand up repeatedly from a chair for 30 seconds with their arms across their chest. Investigators will measure the number of repetitions in one set.
Change from baseline in time for Five Times Sit to Stand Test at week 12
Time frame: Baseline, 12 week and at a 6-week follow-up
The Five Times Sit to Stand Test scoring is based on the amount of time (to the nearest decimal in seconds) a participant is able to transfer from a seated to a standing position and back to sitting five times with their arms across their chest. Test is used to asses functional lower limbs strength, balance, and fall risk.
Change from baseline in lower body flexibility at week 12
Time frame: Baseline and 12 week
The participant sits on the edge of a chair. One foot must remain flat on the floor, while the other leg is extended forward with the knee straight, heel on the floor, and ankle bent at a 90° angle. One hand is placed on top of the other, with the middle fingers aligned. The participant reaches forward towards the toes by bending at the hips. The back remains straight. The final position is held for 2 seconds. Investigators measure the distance between the fingertips and the toes. Two trials are performed, and the better result is considered.
Change from baseline in Timed up-and-go test (TUG) at week 12 and at a 6-week follow-up
Time frame: Baseline, week 12 and at 6-week follow-up
Timed up-and-go test measures functional mobility and balance. Participants will start seated in a chair with armrests. Upon the investigator's signal, participants will rise from the chair, walk 3 meters forward, turn around, walk back to the chair, and sit down. The time taken to complete the task will be recorded to the nearest tenth of a second. The test will be performed three times, and the best time will be recorded for analysis.
Change from baseline in 10-Step Stair Climb Test (SCT) at week 12 and at a 6-week follow-up
Time frame: Baseline, week 12 and at 6-week follow-up
After the practice trial, participants will perform one test trial, during which they will be instructed to ascend and descend a flight of 10 stairs as quickly as possible while maintaining safety. The time taken to complete the task will be recorded to the nearest tenth of a second.
Change from baseline in 6-minute walk distance at week 12
Time frame: Baseline and 12 week
6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome.
Change from baseline in maximal isometric voluntary contraction of knee flexors and extensors at week 12
Time frame: Baseline and week 12
Maximal isometric voluntary contraction of knee flexion and extension will be performed using a knee dynamometer (S2P, Science in Practice, Ltd., Ljubljana, Slovenia), which will allow knee flexion and extension under static conditions with a knee joint angle of 60° and hip flexion in a seated position at 90°. A support will be placed over the ankle (2-3 cm above the lateral malleolus), through which the participant will press against the measuring part of the device. Before the measurement, the participant will perform two repetitions of flexion and extension with submaximal force, aimed at warming up the participant and familiarizing them with the test requirements. This will be followed by 3 muscle contractions with a 3-second hold at the maximum force produced, during which the participant will be verbally encouraged to achieve maximum strength.
6 secondary outcomes
Change from baseline in presence of inflammatory markers in blood sample at week 12
Time frame: Baseline and week 12
Change from baseline in 24-hour time use at week 12
Time frame: Baseline and 12 week
Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12
Time frame: Baseline and week 12
Change from baseline in handgrip strength at week 12
Time frame: Baseline and week 12
Change from baseline in number of repetitions in Arm Curl Test at week 12
Time frame: Baseline and 12 week
Change from baseline in upper body flexibility at week 12
Time frame: Baseline and 12 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 41772729Ceh T, Zavrsnik J, Sarabon N. Complementary effect of a combined exercise and dietary supplement intervention in individuals with knee osteoarthritis: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2026 Mar 3;27(1):274. doi: 10.1186/s13063-026-09594-7.
- Derived from this study: PubMed 41559644Ceh T, Zavrsnik J, Sarabon N, Prosen M. Experiences and perceptions of a 12-week combined exercise and dietary supplement program for individuals with knee osteoarthritis: a qualitative focus group study. BMC Musculoskelet Disord. 2026 Jan 20;27(1):145. doi: 10.1186/s12891-026-09509-2.
- Individual participant dataSharing planned: No
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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.
Nejc Šarabon, PhD study chair
University of Primorska, Faculty of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-training Real Dietary Supplement (G1) and Training Real Dietary Supplement (G3) in people with Osteoarthritis, Knee, run by University of Primorska at 2 sites in Slovenia.
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 3 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 and at a 6-week follow-up (time frame: Baseline, week 12 and at a 6-week follow-up). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06269549, which also lists 2 linked publications.
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 Feb 2026.