OsteoarthritisOléograpeSEEDNCT02566798
Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive
A study testing Extract of grape and olive and Lactose in people with Osteoarthritis, run by Nantes University Hospital at 1 site in France.
Trial summary
Osteoarthritis is a degenerative disease that affects a growing proportion of the population. There is currently no treatment to halt this process. The aim of the research is in particular to find treatments targeting the molecular origins of osteoarthritis focusing especially on the inflammatory component of the… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Extract of grape and olive and Lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Apr 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years old and over
- Patients with knee osteoarthritis (ACR criteria)
- Patients requiring injection of hyaluronic acid (no corticosteroid associated)
- Radiological stage of knee osteoarthritis 1, 2 or 3 (Kellgren-Lawrence)
- Informed consent form signed
Who cannot join
- younger than 50 years
- protected adult
- Pregnant woman
- Radiological Stage 4 osteoarthritis (Kellgren-Lawrence)
- knee osteoarthritis secondary to arthritis
- Taking a long term treatment of osteoarthritis (Piasclédine®, Diacéréine®, glucosamine, chondroitin)
Show all 14Show fewer
- inflammatory pathology other than osteoarthritis
- Taking anti-inflammatory medications
- Refusal to participate in the study
- Use of food supplements with anti-inflammatory properties
- Arthroscopy less than 6 months
- corticosteroid injection <3 months
- INR> 4 or TCA> 2 (anticoagulants)
- Being allergic to lactose
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis is a degenerative disease that affects a growing proportion of the population. There is currently no treatment to halt this process. The aim of the research is in particular to find treatments targeting the molecular origins of osteoarthritis focusing especially on the inflammatory component of the disease. That is why research is looking to the development of preventive treatments like nutraceuticals. This project aims to determine the anti-inflammatory properties of sera of patients who received supplementation of their diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be collected during visits for hyaluronic acid injections in OA patients. These sera will be tested in vitro in a model of inflamed chondrocytes.
- Conditions
- Osteoarthritis
- Being tested
- Extract of grape and olive, Lactose
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extract of grape and oliveDrug
Also called OleograpeSEED
Patients are taking capsules of OleograpeSEED 3 times a day (1mg/day) in the morning, at noon and in the evening during 7 days.
Blood samples and synovial fluid are performed on D0 and D7
LactoseDrug
Patients are taking capsules of placebo 3 times a day in the morning, at noon and in the evening during 7 days.
Blood samples and synovial fluid are performed on D0 and D7
| Study group | Role | What they receive |
|---|---|---|
| Oleogrape | Experimental | Patients are taking capsules of OleograpeSEED (Extract of grape and olive) 3 times a day (1mg/day) in the morning, at noon and in the evening during 7 days Receives: Drug: Extract of grape and olive |
| Placebo | Placebo comparator | Patients are taking capsules of placebo (lactose) 3 times a day in the morning, at noon and in the evening during 7 days Receives: Drug: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
Measured: 7 days
biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
Measured: 7 days
Secondary outcomes (1)
qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566798
- Sponsor's protocol ID
- RC15_0173
- Acronym
- OléograpeSEED
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive
- ClinicalTrials.gov ID
- NCT02566798
- Acronym / sponsor ID
- OléograpeSEED / RC15_0173
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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.
Osteoarthritis is a degenerative disease that affects a growing proportion of the population. There is currently no treatment to halt this process. The aim of the research is in particular to find treatments targeting the molecular origins of osteoarthritis focusing especially on the inflammatory component of the disease. That is why research is looking to the development of preventive treatments like nutraceuticals. This project aims to determine the anti-inflammatory properties of sera of patients who received supplementation of their diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be collected during visits for hyaluronic acid injections in OA patients. These sera will be tested in vitro in a model of inflamed chondrocytes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oleogrape | Experimental | Drug: Extract of grape and olivePatients are taking capsules of OleograpeSEED (Extract of grape and olive) 3 times a day (1mg/day) in the morning, at noon and in the evening during 7 days |
| Placebo | Placebo comparator | Drug: LactosePatients are taking capsules of placebo (lactose) 3 times a day in the morning, at noon and in the evening during 7 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 years old and over
- Patients with knee osteoarthritis (ACR criteria)
- Patients requiring injection of hyaluronic acid (no corticosteroid associated)
- Radiological stage of knee osteoarthritis 1, 2 or 3 (Kellgren-Lawrence)
- Informed consent form signed
Key exclusion criteria (14 listed)
- younger than 50 years
- protected adult
- Pregnant woman
- Radiological Stage 4 osteoarthritis (Kellgren-Lawrence)
- knee osteoarthritis secondary to arthritis
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 |
|---|---|---|
| Extract of grape and oliveAlso: OleograpeSEEDPatients are taking capsules of OleograpeSEED 3 times a day (1mg/day) in the morning, at noon and in the evening during 7 days. Blood samples and synovial fluid are performed on D0 and D7 | Drug | Oleogrape |
| LactosePatients are taking capsules of placebo 3 times a day in the morning, at noon and in the evening during 7 days. Blood samples and synovial fluid are performed on D0 and D7 | Drug | Placebo |
Primary outcome
biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
Time frame: 7 days
biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
Time frame: 7 days
1 secondary outcome
qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera
Time frame: 7 days
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 24 Jun 2026.
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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 Extract of grape and olive and Lactose in people with Osteoarthritis, run by Nantes University Hospital at 1 site in France.
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 5 inclusion and 14 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 24 Jun 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 France. 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?
biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera (time frame: 7 days). 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 24 Jun 2026.