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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02566798

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Extract of grape and olive Drug: Lactose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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 Other Names: OleograpeSEED
Placebo Comparator: Placebo 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 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

Arm

Intervention/Treatment

Experimental: 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

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

Other Names:

OleograpeSEED

Placebo Comparator: Placebo

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

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

Outcome Measures

Primary Outcome Measures

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

qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT02566798

Other Study ID Numbers:

RC15_0173

First Posted:

Oct 2, 2015

Last Update Posted:

May 20, 2016

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of May 20, 2016