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NCT Number: NCT02566798

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: OleograpeSEED

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

Primary outcomes

  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 outcomes

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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: OléograpeSEED

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2015
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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