Knee OsteoarthritisGAUDÍNCT05633849
Evaluation of the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis
A study testing SMP group in people with Knee Osteoarthritis, run by Solutex GC S.L. at 5 sites in Spain.
Trial summary
The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish sites. Eligible patients were adults younger than 68 years diagnosed with symptomatic knee Osteoarthritis and pain score (VAS) ≥ 5. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SMP group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 5 sitesSpain
- Study dates
- 30 May 2018to 14 Oct 2021
- 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 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults younger than 68 years
- Diagnosis of symptomatic knee OA (according to the American College of Rheumatology [ACR]), primary knee (OA)
- Patients with primary knee arthrosis
- Patients with confirmed 2-3 Kellgren and Lawrence radiologic degree
- Patients with pain Visual Analogue Scale (VAS) score ≥ 5
- Patients that signed informed consent
Who cannot join
- Patients allergic to fish or seafood
- Patients that had an arthroscopy within the last year
- Patients that had been diagnosed with secondary knee osteoarthritis
- Patients with concomitant illnesses such as cardiopathy, pneumopathy, non-compensated nephropathy, neuropathy affecting mobility, non-compensated psychiatric disorder, fibromyalgia, and/or cognitive disorder
- Patients that have received NSAIDs during last 3 weeks previous to join the study
- Patients that hace received chondroitin sulfate, glucosamine, diacerein, corticoids infiltration, and/or platelet-rich plasma infiltration in the knee three months before the study inclusion
- Patients that have had a drug abuse record three years before the inclusion
- Patients that have had a drug abuse record three years before the inclusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Clínica Dr. Rodas
Avilés, Principality of Asturias
Instituto Poal de Reumatología
Barcelona
Medical Services F.C. Barcelona
Barcelona
Medical Services Ath, Club Bilbao
Bilbao, Vizcaya
Clínica Segura
Las Rozas de Madrid, Madrid
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis
The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish sites.
Eligible patients were adults younger than 68 years diagnosed with symptomatic knee Osteoarthritis and pain score (VAS) ≥ 5.
The primary endpoint was the change in pain from baseline to week 12. Secondary endpoints included the comparison in the change of pain, stiffness, and function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between groups from baseline to week 12, the assessment of the constant, intermittent, and total pain according to OMERACT-OARSI score, the changes in health-related quality of life score measured by the EUROQoL-5 questionnaire (16) between both study groups, the use of rescue, and anti-inflammatory medication, and the incidence of adverse events (AEs) during the study.
Read the detailed description
The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish centers in compliance with the World Medical Association Declaration of Helsinki, all its amendments, and national regulations. The Independent Ethic Committee of Hospital U. La Paz (Madrid, Spain) approved this study. All patients gave their written informed consent.
The study duration was 24 weeks, including a screening period, a treatment period with monthly visits from the start of the study until week 12, and a follow-up visit 24 weeks after the study initiation conducted by telephone call.
Participants were instructed to take two 500 mg softgels of LIPINOVA(SPM group) or olive oil placebo (placebo group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks.
Eligible patients were adults younger than 68 years diagnosed with symptomatic knee OA (according to the American College of Rheumatology [ACR]), primary knee (OA), confirmed 2-3 Kellgren and Lawrence radiologic degree (15), and pain Visual Analogue Scale (VAS) score ≥ 5. Patients were excluded if they were allergic to fish or seafood, had an arthroscopy within the last year, had been diagnosed with secondary knee osteoarthritis, cardiopathy, pneumopathy, non-compensated nephropathy, neuropathy affecting mobility, non-compensated psychiatric disorder, fibromyalgia, and/or cognitive disorder. Patients were also excluded if they had received chondroitin sulfate, glucosamine, diacerein, corticoids infiltration, and/or platelet-rich plasma infiltration in the knee three months before the study inclusion, NSAIDs three weeks before the inclusion, and/or hyaluronic acid infiltration in the knee six months before the inclusion. Patients could not have had a drug abuse record three years before the inclusion and have participated in another clinical trial.
The primary endpoint was the change in pain measured on a VAS from baseline to week 12. Secondary endpoints included the comparison in the change of pain, stiffness, and function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between groups from baseline to week 12, the assessment of the constant, intermittent, and total pain according to OMERACT-OARSI score, the changes in health-related quality of life score measured by the EUROQoL-5 questionnaire (16) between both study groups, the use of concomitant, rescue, and anti-inflammatory medication, and the incidence of adverse events (AEs) during the study.
- Conditions
- Knee Osteoarthritis
- Being tested
- SMP group, Placebo group
- Keywords
- SPMs, Resolvins, Osteoarthritis, Pain, Quality of life
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMP groupDietary supplement
Participants were instructed to take two 500 mg softgels of LIPINOVA(SPM group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks
Placebo groupDietary supplement
Participants were instructed to take two 500 mg softgels of olive oil placebo after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | In placebo group, participants were instructed to take two 500 mg olive oil placebo (placebo group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks Receives: Dietary Supplement: Placebo group |
| Specialized pro-resolving mediators (SMP) group | Experimental | In SPM group, Participants were instructed to take two 500 mg softgels of LIPINOVA after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks Receives: Dietary Supplement: SMP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Change in pain measured on a visual analogic scale (VAS) (intragroup). Min: 0 (no pain) max: 10 (the worst pain possible)
Measured: Basal and 12 weeks
Secondary outcomes (11)
Change in Pain (between groups) assessed by Visual Analogic Scale. Min: 0 (no pain) max: 10 (the worst pain possible)
Change in pain (between groups)
Measured: Basal and 12 weeks
Use of Rescue medication and patient drop-outs
Percentage of patients that drops-out the study and percentage of patients that need to use rescue medication during the study
Measured: Basal and 12 weeks
Change in functionality assessed by WOMAC (Eastern Ontario McMaster Universities Osteoarthritis Index) score
Changes in functionality using WOMAC score. Min: 0 (better), max: 96 (worse)
Measured: Basal and 12 weeks
Safety of study product, assessed as percentage of patients suffering adverse events related to study product
% of adverse events related to study product
Measured: 12 weeks
Changes in pain assessed as changes in OMERACT-OARSI score
Changes in OMERACT-OARSI score. Min: 0 (better), max 44 (worse)
Measured: Basal and 12 weeks
Quality of life of patients assessed as changes in EQ-5D-5L score
Changes in Quality of life (EQ-5D). Visual analogue scale (quantitative): min: 0 (worse), max: 100 (better). qualitative variables: mobility, self-care, usual activities, pain/discomfort, anxiety/depression Min: 1 (better); max: 5 (worse)
Measured: Basal and 12 weeks
Inflammatory biomarkers: C-reactive protein (CRP)
Changes in Inflammatory biomarkers: CRP
Measured: Basal and 12 weeks
Inflammatory biomarkers: Interleukin -1 (IL-1)
Changes in Inflammatory biomarkers: IL-1
Measured: Basal and 12 weeks
Inflammatory biomarkers: Interleukin-6 (IL-6),
Changes in Inflammatory biomarkers: IL-6
Measured: Basal and 12 weeks
Inflammatory biomarkers: Interleukin-8 (IL-8)
Changes in Inflammatory biomarkers: IL-8
Measured: Basal and 12 weeks
Inflammatory biomarkers: Tumoral Necrosis Factor -α (TNF-α)
Changes in Inflammatory biomarkers: TNF-α
Measured: Basal and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start30 May 2018
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
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 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
- randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solutex GC S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OAFI Foundation (Osteoarthritis Foundation International)
- Responsible party
- Sponsor
- Investigators
- Gil Rodas, MD, Principal investigator, Medical Services F.C. Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633849
- Sponsor's protocol ID
- GAUDÍ
- Acronym
- GAUDÍ
- Status last verified
- Dec 2022
- First submitted
- 31 Oct 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moller I, Rodas G, Villalon JM, Rodas JA, Angulo F, Martinez N, Verges J. Specialized pro-resolving mediator (SPM)-enriched supplementation modulates inflammatory biomarkers in patients with symptomatic knee osteoarthritis: Blood plasma analysis from the GAUDI study. Prostaglandins Leukot Essent Fatty Acids. 2026 Jun 10;210:102758. doi: 10.1016/j.plefa.2026.102758. Online ahead of print.
PubMed 42314382Moller I, Rodas G, Villalon JM, Rodas JA, Angulo F, Martinez N, Verges J. Randomized, double-blind, placebo-controlled study to evaluate the effect of treatment with an SPMs-enriched oil on chronic pain and inflammation, functionality, and quality of life in patients with symptomatic knee osteoarthritis: GAUDI study. J Transl Med. 2023 Jun 29;21(1):423. doi: 10.1186/s12967-023-04283-4.
PubMed 37386594
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05633849
- Acronym / sponsor ID
- GAUDÍ / GAUDÍ
- Conditions
- Knee Osteoarthritis
- Keywords
- SPMs, Resolvins, Osteoarthritis, Pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Solutex GC S.L.Industry (pharma, biotech, devices)
- Collaborators
- OAFI Foundation (Osteoarthritis Foundation International)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 1 Dec 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.
The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish sites.
Eligible patients were adults younger than 68 years diagnosed with symptomatic knee Osteoarthritis and pain score (VAS) ≥ 5.
The primary endpoint was the change in pain from baseline to week 12. Secondary endpoints included the comparison in the change of pain, stiffness, and function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between groups from baseline to week 12, the assessment of the constant, intermittent, and total pain according to OMERACT-OARSI score, the changes in health-related quality of life score measured by the EUROQoL-5 questionnaire (16) between both study groups, the use of rescue, and anti-inflammatory medication, and the incidence of adverse events (AEs) during the study.
Detailed description
The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish centers in compliance with the World Medical Association Declaration of Helsinki, all its amendments, and national regulations. The Independent Ethic Committee of Hospital U. La Paz (Madrid, Spain) approved this study. All patients gave their written informed consent.
The study duration was 24 weeks, including a screening period, a treatment period with monthly visits from the start of the study until week 12, and a follow-up visit 24 weeks after the study initiation conducted by telephone call.
Participants were instructed to take two 500 mg softgels of LIPINOVA(SPM group) or olive oil placebo (placebo group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks.
Eligible patients were adults younger than 68 years diagnosed with symptomatic knee OA (according to the American College of Rheumatology [ACR]), primary knee (OA), confirmed 2-3 Kellgren and Lawrence radiologic degree (15), and pain Visual Analogue Scale (VAS) score ≥ 5. Patients were excluded if they were allergic to fish or seafood, had an arthroscopy within the last year, had been diagnosed with secondary knee osteoarthritis, cardiopathy, pneumopathy, non-compensated nephropathy, neuropathy affecting mobility, non-compensated psychiatric disorder, fibromyalgia, and/or cognitive disorder. Patients were also excluded if they had received chondroitin sulfate, glucosamine, diacerein, corticoids infiltration, and/or platelet-rich plasma infiltration in the knee three months before the study inclusion, NSAIDs three weeks before the inclusion, and/or hyaluronic acid infiltration in the knee six months before the inclusion. Patients could not have had a drug abuse record three years before the inclusion and have participated in another clinical trial.
The primary endpoint was the change in pain measured on a VAS from baseline to week 12. Secondary endpoints included the comparison in the change of pain, stiffness, and function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between groups from baseline to week 12, the assessment of the constant, intermittent, and total pain according to OMERACT-OARSI score, the changes in health-related quality of life score measured by the EUROQoL-5 questionnaire (16) between both study groups, the use of concomitant, rescue, and anti-inflammatory medication, and the incidence of adverse events (AEs) during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupIn placebo group, participants were instructed to take two 500 mg olive oil placebo (placebo group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks |
| Specialized pro-resolving mediators (SMP) group | Experimental | Dietary Supplement: SMP groupIn SPM group, Participants were instructed to take two 500 mg softgels of LIPINOVA after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults younger than 68 years
- Diagnosis of symptomatic knee OA (according to the American College of Rheumatology [ACR]), primary knee (OA)
- Patients with primary knee arthrosis
- Patients with confirmed 2-3 Kellgren and Lawrence radiologic degree
- Patients with pain Visual Analogue Scale (VAS) score ≥ 5
Key exclusion criteria (8 listed)
- Patients allergic to fish or seafood
- Patients that had an arthroscopy within the last year
- Patients that had been diagnosed with secondary knee osteoarthritis
- Patients with concomitant illnesses such as cardiopathy, pneumopathy, non-compensated nephropathy, neuropathy affecting mobility, non-compensated psychiatric disorder, fibromyalgia, and/or cognitive disorder
- Patients that have received NSAIDs during last 3 weeks previous to join the study
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 |
|---|---|---|
| SMP groupParticipants were instructed to take two 500 mg softgels of LIPINOVA(SPM group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks | Dietary supplement | Specialized pro-resolving mediators (SMP) group |
| Placebo groupParticipants were instructed to take two 500 mg softgels of olive oil placebo after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks | Dietary supplement | Placebo group |
Primary outcome
Change in Pain
Time frame: Basal and 12 weeks
Change in pain measured on a visual analogic scale (VAS) (intragroup). Min: 0 (no pain) max: 10 (the worst pain possible)
11 secondary outcomes
Change in Pain (between groups) assessed by Visual Analogic Scale. Min: 0 (no pain) max: 10 (the worst pain possible)
Time frame: Basal and 12 weeks
Use of Rescue medication and patient drop-outs
Time frame: Basal and 12 weeks
Change in functionality assessed by WOMAC (Eastern Ontario McMaster Universities Osteoarthritis Index) score
Time frame: Basal and 12 weeks
Safety of study product, assessed as percentage of patients suffering adverse events related to study product
Time frame: 12 weeks
Changes in pain assessed as changes in OMERACT-OARSI score
Time frame: Basal and 12 weeks
Quality of life of patients assessed as changes in EQ-5D-5L score
Time frame: Basal and 12 weeks
Inflammatory biomarkers: C-reactive protein (CRP)
Time frame: Basal and 12 weeks
Inflammatory biomarkers: Interleukin -1 (IL-1)
Time frame: Basal and 12 weeks
Inflammatory biomarkers: Interleukin-6 (IL-6),
Time frame: Basal and 12 weeks
Inflammatory biomarkers: Interleukin-8 (IL-8)
Time frame: Basal and 12 weeks
Inflammatory biomarkers: Tumoral Necrosis Factor -α (TNF-α)
Time frame: Basal and 12 weeks
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 7 Dec 2022.
- Derived from this study: PubMed 42314382Moller I, Rodas G, Villalon JM, Rodas JA, Angulo F, Martinez N, Verges J. Specialized pro-resolving mediator (SPM)-enriched supplementation modulates inflammatory biomarkers in patients with symptomatic knee osteoarthritis: Blood plasma analysis from the GAUDI study. Prostaglandins Leukot Essent Fatty Acids. 2026 Jun 10;210:102758. doi: 10.1016/j.plefa.2026.102758. Online ahead of print.
- Derived from this study: PubMed 37386594Moller I, Rodas G, Villalon JM, Rodas JA, Angulo F, Martinez N, Verges J. Randomized, double-blind, placebo-controlled study to evaluate the effect of treatment with an SPMs-enriched oil on chronic pain and inflammation, functionality, and quality of life in patients with symptomatic knee osteoarthritis: GAUDI study. J Transl Med. 2023 Jun 29;21(1):423. doi: 10.1186/s12967-023-04283-4.
- 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.
Gil Rodas, MD principal investigator
Medical Services F.C. Barcelona
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMP group in people with Knee Osteoarthritis, run by Solutex GC S.L. at 5 sites in Spain.
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 6 inclusion and 8 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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. Some participants in this study may receive a placebo. 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?
Change in Pain (time frame: Basal and 12 weeks). 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 NCT05633849, 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 7 Dec 2022.