Knee DiscomfortNCT06650670
Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults
A study testing Dietary Supplement: EPP in people with Knee Discomfort, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The objective of this trial is to determine the efficacy of oral administration of a bioactive compound (EPP) in healthy individuals with mild knee joint discomfort. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Discomfort
- What is being tested?
- Dietary Supplement: EPP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 15 Dec 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants (men and women) between 35 and 65 years of age with knee discomfort.
- Mild knee joint pain (visual analog scale between 3 and 6 cm).
Who cannot join
- People with clinical osteoarthritis or any other degenerative joint disease.
- Persons receiving treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, HA, diacerein) two weeks prior to screening.
- Persons receiving intra-articular injections in the knee joint in the 3 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Controlled Nutritional Intervention Study of Parallel Groups to Evaluate the Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults
The objective of this trial is to determine the efficacy of oral administration of a bioactive compound (EPP) in healthy individuals with mild knee joint discomfort.
Read the detailed description
It is estimated that the incidence of osteoarthritis (OA) is increasing exponentially worldwide, with serious consequences, not only on the quality of life and functionality of the subjects, but also a high burden on the social and health care systems of the countries. Existing treatments for OA are either invasive, and therefore risky for the subject and high cost, or have side effects and cannot be maintained over time. Therefore, there is a high demand to find effective and safe therapies to prevent and/or treat OA, such as functional ingredients or compounds present in food. In this regard, our experimental bioactive compound has been developed and shown to be safe and effective in reducing joint pain and improving quality of life in a previous study.
The aim of this study is to evaluate the effect of the consumption of our bioactive compound, in healthy Spanish individuals with mild joint discomfort in the knee.
- Conditions
- Knee Discomfort
- Being tested
- Dietary Supplement: Placebo, Dietary Supplement: EPP
- Keywords
- extract, bioactive compound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: PlaceboDietary supplement
Each participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits
Dietary Supplement: EPPDietary supplement
Each participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group that will receive two capsules with the maltodextrin per day during 12 weeks Receives: Dietary Supplement: Dietary Supplement: Placebo |
| EPP group | Experimental | Experimental group that will receive two capsules with the bioactive compound per day during 12 weeks Receives: Dietary Supplement: Dietary Supplement: EPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS test total score.
Using of the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.
Measured: 12 weeks
Secondary outcomes (6)
KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).
Using the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.
Measured: 12 weeks
VPS scale for knee pain (general and after physical tests performed at the visits).
Using a Visual Pain Scale for Knee Pain
Measured: 12 weeks
Objective assessment of physical activity.
The mobility of your knee will be assessed with a goniometer, the sit-to-stand test will be performed, and accelerometers will be collected to assess physical activity and sedentary lifestyle.
Measured: 12 weeks
Range of motion of the knee joint.
The mobility of your knee will be assessed with a goniometer, the sit-to-stand test will be performed, and accelerometers will be collected to assess physical activity and sedentary lifestyle.
Measured: 12 weeks
Changes observed between baseline and final MRI.
Analyzing cartilage by MRI
Measured: 12 weeks
Lower body strength and power.
The mobility of your knee will be assessed with a goniometer, the sit-to-stand test will be performed, and accelerometers will be collected to assess physical activity and sedentary lifestyle.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Dec 2022
- Primary completion1 Aug 2023
- Study completion15 Dec 2023
Why it stopped: Loss of the strategic interest because the market potential is insufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiscomfortStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada, University Hospital Virgen de las Nieves
- Responsible party
- Sponsor
- Investigators
- Jonatan Ruiz Ruiz, Dr., Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650670
- Sponsor's protocol ID
- C030
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled Nutritional Intervention Study of Parallel Groups to Evaluate the Effect of Consuming a Bioactive Compound (EPP) on Joint Health in Healthy Adults
- ClinicalTrials.gov ID
- NCT06650670
- Acronym / sponsor ID
- C030
- Conditions
- Knee Discomfort
- Keywords
- extract, bioactive compound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of the strategic interest because the market potential is insufficient
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada, University Hospital Virgen de las Nieves
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Oct 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 objective of this trial is to determine the efficacy of oral administration of a bioactive compound (EPP) in healthy individuals with mild knee joint discomfort.
Detailed description
It is estimated that the incidence of osteoarthritis (OA) is increasing exponentially worldwide, with serious consequences, not only on the quality of life and functionality of the subjects, but also a high burden on the social and health care systems of the countries. Existing treatments for OA are either invasive, and therefore risky for the subject and high cost, or have side effects and cannot be maintained over time. Therefore, there is a high demand to find effective and safe therapies to prevent and/or treat OA, such as functional ingredients or compounds present in food. In this regard, our experimental bioactive compound has been developed and shown to be safe and effective in reducing joint pain and improving quality of life in a previous study.
The aim of this study is to evaluate the effect of the consumption of our bioactive compound, in healthy Spanish individuals with mild joint discomfort in the knee.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Dietary Supplement: PlaceboControl group that will receive two capsules with the maltodextrin per day during 12 weeks |
| EPP group | Experimental | Dietary Supplement: Dietary Supplement: EPPExperimental group that will receive two capsules with the bioactive compound per day during 12 weeks |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy participants (men and women) between 35 and 65 years of age with knee discomfort.
- Mild knee joint pain (visual analog scale between 3 and 6 cm).
Key exclusion criteria (3 listed)
- People with clinical osteoarthritis or any other degenerative joint disease.
- Persons receiving treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, HA, diacerein) two weeks prior to screening.
- Persons receiving intra-articular injections in the knee joint in the 3 months prior to 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 |
|---|---|---|
| Dietary Supplement: PlaceboEach participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | Control group |
| Dietary Supplement: EPPEach participant will consume 2 capsules per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | EPP group |
Primary outcome
KOOS test total score.
Time frame: 12 weeks
Using of the KOOS (Knee Injury \& Osteoarthritis Outcomes) Questionnaire.
6 secondary outcomes
KOOS Subscales score (pain, symptoms, daily activity, sport and quality of life).
Time frame: 12 weeks
VPS scale for knee pain (general and after physical tests performed at the visits).
Time frame: 12 weeks
Objective assessment of physical activity.
Time frame: 12 weeks
Range of motion of the knee joint.
Time frame: 12 weeks
Changes observed between baseline and final MRI.
Time frame: 12 weeks
Lower body strength and power.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Loss of the strategic interest because the market potential is insufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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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.
Jonatan Ruiz Ruiz, Dr. principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: EPP in people with Knee Discomfort, run by Biosearch S.A. 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Oct 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 was stopped early (reason given: Loss of the strategic interest because the market potential is insufficient). Results are not available in the source record.
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?
KOOS test total score. (time frame: 12 weeks). 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 21 Oct 2024.