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

May 19, 2016 updated by: Nantes University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC15_0173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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