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

NCT ID: NCT02566798

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-04-30

Brief 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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Oleogrape

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

Group Type: EXPERIMENTAL

Extract of grape and olive

Intervention Type: DRUG

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

Placebo

Patients are taking capsules of placebo (lactose) 3 times a day in the morning, at noon and in the evening during 7 days

Group Type: PLACEBO_COMPARATOR

Lactose

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

OleograpeSEED

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RC15_0173

Identifier Type: -

Identifier Source: org_study_id