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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extract of grape and olive
Lactose
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Oleogrape

    Placebo

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
    biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 30, 2015
    Last Updated
    May 19, 2016
    Sponsor
    Nantes University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02566798
    Brief Title
    Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive
    Acronym
    OléograpeSEED
    Official Title
    Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nantes University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oleogrape
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients are taking capsules of placebo (lactose) 3 times a day in the morning, at noon and in the evening during 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Extract of grape and olive
    Other Intervention Name(s)
    OleograpeSEED
    Intervention Description
    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
    Intervention Name(s)
    Lactose
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
    Time Frame
    7 days
    Title
    biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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