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Trial record 12 of 37 for:    olive extract

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

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ClinicalTrials.gov Identifier: NCT02566798
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : December 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: 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





Primary Outcome Measures :
  1. biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera [ Time Frame: 7 days ]
  2. 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 Measures :
  1. qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera [ Time Frame: 7 days ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02566798     History of Changes
Other Study ID Numbers: RC15_0173
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: September 2015
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents