An oleuropein-based dietary supplement may improve joint functional capacity in older people with high knee joint pain: findings from a multicentre-RCT and post hoc analysis

Marie-Noëlle Horcajada; Maurice Beaumont; Nicolas Sauvageot; Laure Poquet; Madleen Saboundjian; Berenice Costes; Peter Verdonk; Geoffrey Brands; Jean Brasseur; Didier Urbin-Choffray; Marc Vandenberghe; Karl Brabants; Kurt De Vlam; Werner Fache; Bernard Jandrain; Vincent Grek; Michel Malaise; Yves Henrotin

doi:10.1177/1759720X211070205

An oleuropein-based dietary supplement may improve joint functional capacity in older people with high knee joint pain: findings from a multicentre-RCT and post hoc analysis

Ther Adv Musculoskelet Dis. 2022 Jan 19:14:1759720X211070205. doi: 10.1177/1759720X211070205. eCollection 2022.

Authors

Marie-Noëlle Horcajada¹, Maurice Beaumont², Nicolas Sauvageot², Laure Poquet³, Madleen Saboundjian³, Berenice Costes⁴, Peter Verdonk⁵, Geoffrey Brands⁶, Jean Brasseur⁷, Didier Urbin-Choffray⁸, Marc Vandenberghe⁹, Karl Brabants¹⁰, Kurt De Vlam¹¹, Werner Fache¹², Bernard Jandrain¹³, Vincent Grek¹⁴, Michel Malaise¹⁵, Yves Henrotin¹⁶

Affiliations

¹ Musculoskeletal Health Department, Nestle Research, EPFL Innovation Park, 1015 Lausanne, Switzerland.
² Nestle Research, Vers-chez-les-Blanc, Lausanne, Switzerland.
³ Nestle Research, EPFL Innovation Park, Lausanne, Switzerland.
⁴ Artialis SA, CHU Sart-Tilman, Liège, Belgium.
⁵ Antwerpen Orthopedic Center, Antwerpen, Belgium.
⁶ CHC, Clinique Saint-Joseph, Liège, Belgium.
⁷ CHU UCL Namur, Site Mont-Godinne, Yvoir, Belgium.
⁸ Centre Hospitalier Régional de la Citadelle, Liège, Belgium.
⁹ Grand Hôpital de Charleroi, Charleroi, Belgium.
¹⁰ ZNA Middelheim, Antwerpen, Belgium.
¹¹ ZNA Jan Palfijn, Merksem, Belgium.
¹² Linus Pauling Preventie Centrum, Gent, Belgium.
¹³ Clinical Pharmacology Unit, ATC S.A., Liège, Belgium.
¹⁴ 2B Clinic, Wavre, Belgium.
¹⁵ CHU Sart-Tilman, Liège, Belgium.
¹⁶ musculoSKeletal Innovative research Lab (mSKIL), The Center for Interdisciplinary Research on Medicines (CIRM), Department of Motricity Center, Institute of Pathology, University of Liège, CHU Sart-Tilman, 4000 Liège, Belgium; Artialis SA, CHU Sart-Tilman, Liège, Belgium; Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Vivalia, Marche-en-Fammenne, Belgium.

Abstract

Objectives: To investigate a 6-month intervention with an olive leaf extract (OLE) on knee functionality and biomarkers of bone/cartilage metabolism and inflammation.

Design: This randomized, double-blind, placebo-controlled, multi-centric trial included 124 subjects with knee pain or mobility issues. Subjects received twice a day one capsule of placebo or 125 mg OLE (Bonolive^™, an OLE containing 50 mg of oleuropein) for 6 months. The co-primary endpoints were Knee injury and Osteoarthritis Outcome Score (KOOS) and serum Coll2-1NO2. The secondary endpoints were the subscales of the KOOS, knee pain VAS at rest and at walking, OARSI core set of performance-based tests and multiple inflammatory and bone or cartilage remodeling serum biomarkers and concentration of oleuropein's metabolites in urine.

Results: At 6 months, OLE group was not efficient on global KOOS score, changes of inflammatory and cartilage remodeling biomarkers compared to placebo. Post hoc analyses demonstrated a large and significant treatment effect of OLE in a sub-group of subjects with high walking pain at baseline (p = 0.03). This was observed at 6 months for the global KOOS score, and each different subscale and for pain at walking (p = 0.02). OLE treatment was well tolerated.

Conclusion: OLE was not effective on joint discomfort excepted in a sub-group of subjects with high pain at treatment initiation. As oleuropein is well tolerated, OLE can be used to relieve knee joint pain and enhance mobility in subjects with articular pain.

Keywords: function; joint pain; nutritional supplement; oleuropein.