Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive

Study Overview
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Brief Summary
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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.

Official Title
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Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Extract of grape and olive
* Drug: Lactose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oleogrape<br>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 | Drug: Extract of grape and olive<br>* 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<br>* Other names: OleograpeSEED;|
| Placebo Comparator: Placebo<br>Patients are taking capsules of placebo (lactose) 3 times a day in the morning, at noon and in the evening during 7 days | Drug: Lactose<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera |  | 7 days | 
| biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera |  | 7 days |