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

Osteoarthritis Clinical Trial

— OléograpeSEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566798
• Other study ID #: RC15_0173
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: May 19, 2016
• Start date: December 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Extract of grape and olive
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
• Lactose
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera		7 days	No
Primary	biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera		7 days	No
Secondary	qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera		7 days	No