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

NCT02566798 | Completed

• 1 other identifier: RC15_0173
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera

  7 days

Study Arms (2)

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

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

Drug: Lactose

Interventions

Extract of grape and olive 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

Also known as: OleograpeSEED

Oleogrape

Lactose 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

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Lactose

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 2, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2015-09