Osteoarthritis, KneeNUVICOLNCT07870967
Undenatured Type II Collagen for Knee Osteoarthritis Pain
A study testing Nuvicol II and Nuvicol SII in people with Osteoarthritis, Knee, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
This randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 31 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Nuvicol II and Nuvicol SII
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2027to Jul 2027
- 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 31 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 30 years.
- Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified American College of Rheumatology criteria.
- Persistent knee pain associated with osteoarthritis with a baseline VAS pain assessment score of at least 30 mm.
- Subjects must not have narcotic or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.
Who cannot join
- Serious or terminal illnesses.
- Allergy or hypersensitivity to any component of the product under study.
- Vegan or vegetarian diet.
- Current use of glucosamine, chondroitin sulfate, collagen, hyaluronic infiltrations, or any supplement indicated for joint health.
- Chronic inflammatory diseases affecting the musculoskeletal system, including rheumatoid arthritis, gout, pseudogout, Paget disease, or chronic pain syndrome.
- Body mass index above 32 kg/m2.
Show all 10Show fewer
- Participation in any other research during the last 3 months.
- Pregnant, planning pregnancy during the study, lactating, or breastfeeding.
- Biological childbearing potential without continuous effective contraception as determined by the investigator.
- Inability to understand the research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
UCAM HiTech - Unidad de Estudios Clínicos
Murcia, Murcia, 30107
Javier Marhuenda, PhD
About this study
Official title: Randomized Clinical Trial to Analyze the Efficacy and Safety of Undenatured Type II Collagen Product on Joint Pain in Patients Diagnosed With Osteoarthritis
This randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Participants will be randomized to Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), or placebo and will consume one capsule daily for 4 months. Pain, quality of life, knee muscle function, concomitant analgesic medication use, cartilage degradation biomarkers, safety laboratory variables, and adverse events will be assessed during follow-up.
Read the detailed description
Participants diagnosed with osteoarthritis and persistent knee pain will be randomized in equal proportion to one of three parallel arms: Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), or placebo. The study product will be consumed once daily for 4 months. Assessments include baseline laboratory visits, home controls at approximately 30 and 90 days, an intermediate visit at approximately 60 days, and a final visit at approximately 120 days. The primary efficacy assessment is joint pain measured with a visual analog scale. Secondary assessments include KOOS and WOMAC questionnaires, concomitant analgesic medication use, knee muscle function by isometric and isokinetic dynamometry, biomarkers of cartilage degradation, blood safety analysis, and adverse events.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Placebo, Nuvicol II, Nuvicol SII
- Keywords
- Joint Pain, Undenatured Type II Collagen, Visual Analog Scale
- Medical subject headings
- Osteoarthritis, Knee, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Matching placebo capsules containing maltodextrin and magnesium stearate, orally once daily for 4 months.
Nuvicol IIDietary supplement
Also called nuvicol® II
Undenatured type II collagen from chicken source, 40 mg orally once daily for 4 months.
Nuvicol SIIDietary supplement
Also called nuvicol® S II
Undenatured type II collagen from salmon source, 40 mg orally once daily for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Nuvicol II (nuvicol® II) | Experimental | Participants receive Nuvicol II (nuvicol® II), undenatured type II collagen from chicken source, 40 mg once daily for 4 months. Receives: Dietary Supplement: Nuvicol II |
| Nuvicol SII (nuvicol® S II) | Experimental | Participants receive Nuvicol SII (nuvicol® S II), undenatured type II collagen from salmon source, 40 mg once daily for 4 months. Receives: Dietary Supplement: Nuvicol SII |
| Placebo | Placebo comparator | Participants receive matching placebo capsules containing maltodextrin and magnesium stearate once daily for 4 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in joint pain intensity measured by visual analog scale
Joint pain intensity will be measured using a 10-cm visual analog scale. The participant marks pain intensity from 0, no pain, to 10, worst imaginable pain. The primary endpoint is change from baseline in VAS pain score.
Measured: Baseline to 16 weeks
Secondary outcomes (8)
Change in knee-related quality of life measured by KOOS
KOOS evaluates pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0 to 100 scale, where 0 represents extreme knee problems and 100 represents no knee problems.
Measured: Baseline to 16 weeks; also assessed at 30, 60, and 90 days
Change in pain, stiffness, and physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index assesses pain, stiffness, and physical function in participants with knee osteoarthritis. The total score ranges from 0 to 96, with higher scores indicating worse symptoms and physical function.
Measured: Baseline to 16 weeks; also assessed at 30, 60, and 90 days
Change in concomitant analgesic medication use
Daily prescribed and rescue analgesic medication use will be recorded to evaluate changes in the need for analgesic medication.
Measured: Baseline to 16 weeks
Change in knee muscle function by dynamometry
Isometric and isokinetic knee muscle function will be measured with a Biodex System 3 dynamometer in the painful knee, including extension and flexion assessments.
Measured: Baseline, 8 weeks, and 16 weeks
Change in serum cartilage oligomeric matrix protein concentration
Serum cartilage oligomeric matrix protein concentration will be assessed as a biomarker of cartilage degradation and cartilage catabolism.
Measured: Baseline, 8 weeks, and 16 weeks
Change in renal and hepatic blood safety parameters
Biochemical and hematological blood analyses will be used to evaluate renal and hepatic safety parameters during the study.
Measured: Baseline to 16 weeks
Change in urinary C-terminal telopeptide of type II collagen concentration
Urinary C-terminal telopeptide of type II collagen concentration will be assessed as a biomarker of cartilage degradation and treatment response.
Measured: Baseline, 8 weeks, and 16 weeks
Incidence of adverse events
Adverse events will be collected throughout the study to assess product safety.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, double-blind clinical trial with three parallel arms: Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), and placebo. Participants consume the assigned product once daily for 4 months.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Marhuenda, Universidad Católica San Antonio de Murcia
- Investigators
- Javier Marhuenda, PhD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870967
- Sponsor's protocol ID
- NUVICOL
- Acronym
- NUVICOL
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because study data will be coded and managed according to confidentiality and data protection requirements.
Publications
Perez-Pinero S, Munoz-Carrillo JC, Victoria-Montesinos D, Garcia-Munoz AM, Andreu-Caravaca L, Gomez M, Scholzel M, Garcia-Guillen AI, Lopez-Roman FJ. Efficacy of Boswellia serrata Extract and/or an Omega-3-Based Product for Improving Pain and Function in People Older Than 40 Years with Persistent Knee Pain: A Randomized Double-Blind Controlled Clinical Trial. Nutrients. 2023 Sep 3;15(17):3848. doi: 10.3390/nu15173848.
PubMed 37686880
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Analyze the Efficacy and Safety of Undenatured Type II Collagen Product on Joint Pain in Patients Diagnosed With Osteoarthritis
- ClinicalTrials.gov ID
- NCT07870967
- Acronym / sponsor ID
- NUVICOL / NUVICOL
- Conditions
- Osteoarthritis, Knee
- Keywords
- Joint Pain, Undenatured Type II Collagen, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Oct 2026 (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 randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Participants will be randomized to Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), or placebo and will consume one capsule daily for 4 months. Pain, quality of life, knee muscle function, concomitant analgesic medication use, cartilage degradation biomarkers, safety laboratory variables, and adverse events will be assessed during follow-up.
Detailed description
Participants diagnosed with osteoarthritis and persistent knee pain will be randomized in equal proportion to one of three parallel arms: Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), or placebo. The study product will be consumed once daily for 4 months. Assessments include baseline laboratory visits, home controls at approximately 30 and 90 days, an intermediate visit at approximately 60 days, and a final visit at approximately 120 days. The primary efficacy assessment is joint pain measured with a visual analog scale. Secondary assessments include KOOS and WOMAC questionnaires, concomitant analgesic medication use, knee muscle function by isometric and isokinetic dynamometry, biomarkers of cartilage degradation, blood safety analysis, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, controlled, double-blind clinical trial with three parallel arms: Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), and placebo. Participants consume the assigned product once daily for 4 months.
| Arm | Type | Receives |
|---|---|---|
| Nuvicol II (nuvicol® II) | Experimental | Dietary Supplement: Nuvicol IIParticipants receive Nuvicol II (nuvicol® II), undenatured type II collagen from chicken source, 40 mg once daily for 4 months. |
| Nuvicol SII (nuvicol® S II) | Experimental | Dietary Supplement: Nuvicol SIIParticipants receive Nuvicol SII (nuvicol® S II), undenatured type II collagen from salmon source, 40 mg once daily for 4 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants receive matching placebo capsules containing maltodextrin and magnesium stearate once daily for 4 months. |
Who may qualify
- Ages
- 31 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 30 years.
- Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified American College of Rheumatology criteria.
- Persistent knee pain associated with osteoarthritis with a baseline VAS pain assessment score of at least 30 mm.
- Subjects must not have narcotic or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.
Key exclusion criteria (10 listed)
- Serious or terminal illnesses.
- Allergy or hypersensitivity to any component of the product under study.
- Vegan or vegetarian diet.
- Current use of glucosamine, chondroitin sulfate, collagen, hyaluronic infiltrations, or any supplement indicated for joint health.
- Chronic inflammatory diseases affecting the musculoskeletal system, including rheumatoid arthritis, gout, pseudogout, Paget disease, or chronic pain syndrome.
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 |
|---|---|---|
| PlaceboMatching placebo capsules containing maltodextrin and magnesium stearate, orally once daily for 4 months. | Dietary supplement | Placebo |
| Nuvicol IIAlso: nuvicol® IIUndenatured type II collagen from chicken source, 40 mg orally once daily for 4 months. | Dietary supplement | Nuvicol II (nuvicol® II) |
| Nuvicol SIIAlso: nuvicol® S IIUndenatured type II collagen from salmon source, 40 mg orally once daily for 4 months. | Dietary supplement | Nuvicol SII (nuvicol® S II) |
Primary outcome
Change in joint pain intensity measured by visual analog scale
Time frame: Baseline to 16 weeks
Joint pain intensity will be measured using a 10-cm visual analog scale. The participant marks pain intensity from 0, no pain, to 10, worst imaginable pain. The primary endpoint is change from baseline in VAS pain score.
8 secondary outcomes
Change in knee-related quality of life measured by KOOS
Time frame: Baseline to 16 weeks; also assessed at 30, 60, and 90 days
Change in pain, stiffness, and physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline to 16 weeks; also assessed at 30, 60, and 90 days
Change in concomitant analgesic medication use
Time frame: Baseline to 16 weeks
Change in knee muscle function by dynamometry
Time frame: Baseline, 8 weeks, and 16 weeks
Change in serum cartilage oligomeric matrix protein concentration
Time frame: Baseline, 8 weeks, and 16 weeks
Change in renal and hepatic blood safety parameters
Time frame: Baseline to 16 weeks
Change in urinary C-terminal telopeptide of type II collagen concentration
Time frame: Baseline, 8 weeks, and 16 weeks
Incidence of adverse events
Time frame: Baseline to 16 weeks
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 22 Oct 2026.
- Background: PubMed 37686880Perez-Pinero S, Munoz-Carrillo JC, Victoria-Montesinos D, Garcia-Munoz AM, Andreu-Caravaca L, Gomez M, Scholzel M, Garcia-Guillen AI, Lopez-Roman FJ. Efficacy of Boswellia serrata Extract and/or an Omega-3-Based Product for Improving Pain and Function in People Older Than 40 Years with Persistent Knee Pain: A Randomized Double-Blind Controlled Clinical Trial. Nutrients. 2023 Sep 3;15(17):3848. doi: 10.3390/nu15173848.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because study data will be coded and managed according to confidentiality and data protection requirements.
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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.
Javier Marhuenda, PhD principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuvicol II and Nuvicol SII in people with Osteoarthritis, Knee, run by Universidad Católica San Antonio de Murcia at 1 site 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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 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?
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?
Contact Javier Marhuenda, PhD (+34 618, jmarhuenda@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in joint pain intensity measured by visual analog scale (time frame: Baseline to 16 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 NCT07870967, which also lists 1 linked publication.
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 22 Oct 2026.