Joint PainACTIVENCT05282992
NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort
A study testing Native type II collagen in people with Joint Pain, run by Bioiberica at 1 site in Spain.
Trial summary
Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Pain
- What is being tested?
- Native type II collagen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2022to 18 Mar 2024
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2. (see Section 4.0)
- Unilateral or bilateral knee discomfort for greater than 3 months.
- VAS score during knee movement between 30-50 mm after 7-day withdrawal of excluded medications.
- Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10 minutes of going up and down stairs.
- Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator.
- Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol. To do so and be able of using the fitness tracker, a phone or tablet compatible with the Fitbit app is required. (Apple iOS 12.2 or higher, Android OS 7.0 or higher.)
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- Be willing to refrain from taking ibuprofen, aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter) or prescription) during the entire study other than acetaminophen (paracetamol) as rescue medication.
- Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the study.
- Be willing to refrain from taking dietary supplements during the entire study that have any underlying joint benefit (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,…)
Who cannot join
- History of hypersensitivity to the rescue medication or any of the products used in the study.
- Requirement of drugs to control joint discomfort.
- Regular drug intake to control any kind of pain.
- History of hypersensitivity to eggs, chicken, or fowl.
- History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (Rheumatoid Arthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.
- Hyperuricemia (>440 μmol/L), history of gout, or both.
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- Exercising (intentionally) for more than 10 hours a week
- High intensity exercise for more than 5 hours a week
- Anticipation of surgery within the next 6 months.
- Recent injury in the target knee (past 4 months).
- History of congestive heart failure.
- Anticipated problems with product consumption.
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years.
- High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.).
- Females who are pregnant or lactating or planning to become pregnant.
- History of any mental illness that might impair the ability of subjects to provide a written informed consent.
- Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drug osteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroids within 1 week of visit 1, and consumption of Omega 3 fatty acids or any other joint health dietary supplements within 2 weeks preceding the treatment period.
- Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit.
- Consumed acetaminophen (paracetamol) within 48 hours of randomization visit.
- Participation in any clinical trials within 30 days prior to first visit.
- Individuals following an energy restricted diet for weight loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort
Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo.
Read the detailed description
This study will include 100 healthy volunteers in which will be evaluated if the collagen supplement is able to obtain differences versus placebo in pain and function. It will be a randomized, double-blind, placebo-controlled study with proportion 1:1 between treatments
- Conditions
- Joint Pain
- Being tested
- Native type II collagen, Placebo
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native type II collagenDietary supplement
1 capsule/day
PlaceboDietary supplement
1 capsule/day
| Study group | Role | What they receive |
|---|---|---|
| Native type II collagen | Experimental | Native type II collagen Receives: Dietary Supplement: Native type II collagen |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in joint discomfort onset
Determine differences from baseline on reaching a joint pain of 5/1 while going up and down stairs (max 10 min).
Measured: Change in joint discomfort onset at 6 months
Secondary outcomes (6)
Joint discomfort
Visual Analog Scale (VAS, 0-10cm) pain at rest and during activity. A higher VAS means higher pain levels
Measured: Day 0 to day 60, 90, 120, 180
Joint function
Knee injury and Osteoarthritis Outcome Score (KOOS) test
Measured: Day 0 to day 60, 90, 120, 180
Time to Joint discomfort
Time to joint discomfort and to recover from pain in 3 different exercises
Measured: Day 0 to day 60, 90, 120, 180
6 minute walking timed test (6MWT)
Distance a person is capable of walking on a flat, hard surface in 6 minutes
Measured: Day 0 and 180
Rescue medication consumption
Rescue medication: Paracetamol 500mg. max 2 pills/day
Measured: Day 0 to 180, anytime
Cartilage turnover biomarkers
Cartilage turnover biomarkers will be measured in blood and urine (CTX-II, C2C, CPII)
Measured: Day 0 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start3 Mar 2022
- Primary completion14 Nov 2023
- Study completion18 Mar 2024
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 Joint PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282992
- Sponsor's protocol ID
- PJ-00081
- Acronym
- ACTIVE
- Status last verified
- Jan 2023
- First submitted
- 23 Feb 2022
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moller I, Martinez K, Terradillos-Guillen A, Costa-Larrion E, Martinez-Puig D, Velasco-Alvarez J. Efficacy and tolerability of native (undenatured) type II collagen supplementation for joint health in healthy volunteers: a randomized double-blind placebo-controlled study. Nutr J. 2026 Mar 6;25(1):46. doi: 10.1186/s12937-026-01302-0.
PubMed 41787523
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort
- ClinicalTrials.gov ID
- NCT05282992
- Acronym / sponsor ID
- ACTIVE / PJ-00081
- Conditions
- Joint Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 16 Mar 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.
Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo.
Detailed description
This study will include 100 healthy volunteers in which will be evaluated if the collagen supplement is able to obtain differences versus placebo in pain and function. It will be a randomized, double-blind, placebo-controlled study with proportion 1:1 between treatments
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Native type II collagen | Experimental | Dietary Supplement: Native type II collagenNative type II collagen |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2. (see Section 4.0)
- Unilateral or bilateral knee discomfort for greater than 3 months.
- VAS score during knee movement between 30-50 mm after 7-day withdrawal of excluded medications.
- Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10 minutes of going up and down stairs.
- Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator.
Key exclusion criteria (21 listed)
- History of hypersensitivity to the rescue medication or any of the products used in the study.
- Requirement of drugs to control joint discomfort.
- Regular drug intake to control any kind of pain.
- History of hypersensitivity to eggs, chicken, or fowl.
- History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (Rheumatoid Arthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.
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 |
|---|---|---|
| Native type II collagen1 capsule/day | Dietary supplement | Native type II collagen |
| Placebo1 capsule/day | Dietary supplement | Placebo |
Primary outcome
Change in joint discomfort onset
Time frame: Change in joint discomfort onset at 6 months
Determine differences from baseline on reaching a joint pain of 5/1 while going up and down stairs (max 10 min).
6 secondary outcomes
Joint discomfort
Time frame: Day 0 to day 60, 90, 120, 180
Joint function
Time frame: Day 0 to day 60, 90, 120, 180
Time to Joint discomfort
Time frame: Day 0 to day 60, 90, 120, 180
6 minute walking timed test (6MWT)
Time frame: Day 0 and 180
Rescue medication consumption
Time frame: Day 0 to 180, anytime
Cartilage turnover biomarkers
Time frame: Day 0 and 180
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 29 Aug 2024.
- Derived from this study: PubMed 41787523Moller I, Martinez K, Terradillos-Guillen A, Costa-Larrion E, Martinez-Puig D, Velasco-Alvarez J. Efficacy and tolerability of native (undenatured) type II collagen supplementation for joint health in healthy volunteers: a randomized double-blind placebo-controlled study. Nutr J. 2026 Mar 6;25(1):46. doi: 10.1186/s12937-026-01302-0.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native type II collagen in people with Joint Pain, run by Bioiberica 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 9 inclusion and 21 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 29 Aug 2024. 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?
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 joint discomfort onset (time frame: Change in joint discomfort onset at 6 months). 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 NCT05282992, 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 29 Aug 2024.