Symptomatic Knee OsteoarthritisNCT04783792
The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention
A study testing Ascorbic acid / phytochemical supplement and Ascorbic acid in people with Symptomatic Knee Osteoarthritis, run by Harokopio University at 2 sites in Greece.
Trial summary
The main objective of the study is to elucidate the beneficial effect of a dietary supplement with phenolic compounds in patients with OA versus ascorbic acid. The analysis of the data is expected to clarify the role of the new supplement as one with a positive effect on OA-related biomarkers, on functional abilities… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Symptomatic Knee Osteoarthritis
- What is being tested?
- Ascorbic acid / phytochemical supplement and Ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic knee OA (patients with at least moderate symptoms)
- patients should be able to walk without a medical or other support device (such as a walking stick, crutches, or a kneecap).
Who cannot join
- Patients undergoing physical therapy or TENS, have rheumatoid arthritis, fibromyalgia, spinal disorders or any other disorders that according to the physician is a bias, stiffness> 30 minutes, have scheduled knee surgery or any other programmed surgery during the trial, show WOMAC pain scale <4 for pain overall, those with a diagnosis of kidney or liver disease, coagulation disorders, any form of cancer, HIV infection, type I diabetes, those with unregulated type II diabetes, those using illicit substances or having a history of substance or alcohol abuse over the past 2 years (or those who consume more than 2 typical alcoholic beverages / day in the present), those using corticosteroids within 2 months prior to randomization and during the trial, those who change their diet or supplementation 1 month or during the recruitment/trial, those using ascorbic acid supplement or any phytochemical-rich supplement, women on estrogen replacement therapy, during pregnancy or lactation and those judged by the researcher as unable to perceive and comply with the obligations laid down in the Protocol and for which consent and voluntary participation is sought.
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Harokopio University
Athens, Attica, 17671
Evgenidio Hospital
Athens
About this study
Official title: The Effect of Phenolic Cmpounds in Osteoarthritis; a Nutritional Intervention
The main objective of the study is to elucidate the beneficial effect of a dietary supplement with phenolic compounds in patients with OA versus ascorbic acid.
The analysis of the data is expected to clarify the role of the new supplement as one with a positive effect on OA-related biomarkers, on functional abilities and on the quality of life of patients with OA.
- Conditions
- Symptomatic Knee Osteoarthritis
- Being tested
- Ascorbic acid / phytochemical supplement, Ascorbic acid
- Keywords
- symptomatic knee osteoartritis, phenolic compound,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acid / phytochemical supplementDietary supplement
Ascorbic acid / phytochemical supplement
Ascorbic acidDietary supplement
Ascorbic acid
| Study group | Role | What they receive |
|---|---|---|
| ascorbic acid / phytochemical supplement | Experimental | A mixture of active phenolic compounds with ascorbic acid Receives: Dietary Supplement: Ascorbic acid / phytochemical supplement |
| ascorbic acid | Experimental | Ascorbic acid group Receives: Dietary Supplement: Ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC™ Osteoarthritis Index Pain Subscale
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
- Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
- Stiffness (2 items): after first waking and later in the day
- Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 3 months
Visual Analogue Scale - VAS
The Visual Analogue Scale - VAS is a unidimensional measure of pain intensity. It is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
Measured: 3 months
Secondary outcomes (6)
WOMAC™ Osteoarthritis Index Stiffness Score
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
- Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
- Stiffness (2 items): after first waking and later in the day
- Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Measured: 3 months
WOMAC™ Osteoarthritis Index Physical Function Score
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
- Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
- Stiffness (2 items): after first waking and later in the day
- Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Measured: 3 months
Questionnaire SF-36
SF-36 is a self-reporting set of generic, coherent, and easily administered quality-of-life measures.
Measured: 3 months
Circulating Inflammatory markers
IL-1beta, IL-6, IL-13, TNF-alpha, endothelin
Measured: 3 months
Circulating oxidative damage markers
MPO, oxLDL, serum oxidisability
Measured: 3 months
Circulating miRNAs
miR-146a-5p, miR-21-5p, miR-126-3p, miR-155-5p
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Nov 2020
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized double-blind clinical intervention with two parallel groups lasting 3 months is proposed to elucidate the beneficial effect of a novel food supplement on OA. Participants will undergo clinical and biochemical testing and will provide a complete medical history and history of the disease. Demographics, smoking, alcohol consumption, eating habits and physical activity, pain, and functional inability to enroll in the study will also be recorded.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andriana C Kaliora, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783792
- Sponsor's protocol ID
- OA supplement_( )
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phenolic Cmpounds in Osteoarthritis; a Nutritional Intervention
- ClinicalTrials.gov ID
- NCT04783792
- Acronym / sponsor ID
- OA supplement_( )
- Conditions
- Symptomatic Knee Osteoarthritis
- Keywords
- symptomatic knee osteoartritis, phenolic compound,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Mar 2021 (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 main objective of the study is to elucidate the beneficial effect of a dietary supplement with phenolic compounds in patients with OA versus ascorbic acid.
The analysis of the data is expected to clarify the role of the new supplement as one with a positive effect on OA-related biomarkers, on functional abilities and on the quality of life of patients with OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized double-blind clinical intervention with two parallel groups lasting 3 months is proposed to elucidate the beneficial effect of a novel food supplement on OA. Participants will undergo clinical and biochemical testing and will provide a complete medical history and history of the disease. Demographics, smoking, alcohol consumption, eating habits and physical activity, pain, and functional inability to enroll in the study will also be recorded.
| Arm | Type | Receives |
|---|---|---|
| ascorbic acid / phytochemical supplement | Experimental | Dietary Supplement: Ascorbic acid / phytochemical supplementA mixture of active phenolic compounds with ascorbic acid |
| ascorbic acid | Experimental | Dietary Supplement: Ascorbic acidAscorbic acid group |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic knee OA (patients with at least moderate symptoms)
- patients should be able to walk without a medical or other support device (such as a walking stick, crutches, or a kneecap).
Key exclusion criteria (1 listed)
- Patients undergoing physical therapy or TENS, have rheumatoid arthritis, fibromyalgia, spinal disorders or any other disorders that according to the physician is a bias, stiffness> 30 minutes, have scheduled knee surgery or any other programmed surgery during the trial, show WOMAC pain scale <4 for pain overall, those with a diagnosis of kidney or liver disease, coagulation disorders, any form of cancer, HIV infection, type I diabetes, those with unregulated type II diabetes, those using illicit substances or having a history of substance or alcohol abuse over the past 2 years (or those who consume more than 2 typical alcoholic beverages / day in the present), those using corticosteroids within 2 months prior to randomization and during the trial, those who change their diet or supplementation 1 month or during the recruitment/trial, those using ascorbic acid supplement or any phytochemical-rich supplement, women on estrogen replacement therapy, during pregnancy or lactation and those judged by the researcher as unable to perceive and comply with the obligations laid down in the Protocol and for which consent and voluntary participation is sought.
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 |
|---|---|---|
| Ascorbic acid / phytochemical supplementAscorbic acid / phytochemical supplement | Dietary supplement | ascorbic acid / phytochemical supplement |
| Ascorbic acidAscorbic acid | Dietary supplement | ascorbic acid |
Primary outcome
WOMAC™ Osteoarthritis Index Pain Subscale
Time frame: 3 months
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): after first waking and later in the day * Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Visual Analogue Scale - VAS
Time frame: 3 months
The Visual Analogue Scale - VAS is a unidimensional measure of pain intensity. It is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
6 secondary outcomes
WOMAC™ Osteoarthritis Index Stiffness Score
Time frame: 3 months
WOMAC™ Osteoarthritis Index Physical Function Score
Time frame: 3 months
Questionnaire SF-36
Time frame: 3 months
Circulating Inflammatory markers
Time frame: 3 months
Circulating oxidative damage markers
Time frame: 3 months
Circulating miRNAs
Time frame: 3 months
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 1 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic acid / phytochemical supplement and Ascorbic acid in people with Symptomatic Knee Osteoarthritis, run by Harokopio University at 2 sites in Greece.
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 1 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 1 Mar 2023. 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 Greece. 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?
WOMAC™ Osteoarthritis Index Pain Subscale (time frame: 3 months). 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 1 Mar 2023.