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

Journal: Therapeutic advances in musculoskeletal disease 2022;14():1759720X211070205

PMID: 35069812

Plain Language Summary

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Mobility is an important factor for the quality of life and healthy ageing. Yet, most people as they age will experience some degree of mobility issue, typically linked to problems with joints, bones or muscles. Current medical treatments focus on the management of pain and discomfort with anti-inflammatory drugs and pain relief. However, chronic use of these medications is associated with many side effects. Olive leaf extract (OLE) is a rich source of anti-inflammatory and antioxidant compounds such as oleuropein. Animal studies of OLE showed it had promising effects on inflammation and age-related joint degeneration, and in clinical studies, it was demonstrated to preserve bone mineral density. This 6-month randomized placebo-controlled trial investigated the use of 125mg OLE on knee pain, discomfort and loss of mobility in 124 elderly subjects over 55 who experienced mild to moderate pain during or after physical activity in the absence of diagnosed underlying conditions such as osteoarthritis. The outcome was tracked by scoring questionnaires and blood samples to monitor inflammatory markers, as well as urinary samples to assess compliance. At the end of the trial, there was no significant difference in pain or inflammatory markers, apart from a decline in Prostaglandin E2 in the OLE takers. An adjusted analysis showed that whereby people with mild to moderate pain did not experience any benefits, a significant effect was seen in people who had higher levels of baseline pain to begin with. Due to the good safety profile of OLE, it may be a suitable intervention for those candidates. Larger scale trials may help to enhance these findings.

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. analyses demonstrated a large and significant treatment effect of OLE in a sub-group of subjects with high walking pain at baseline ( = 0.03). This was observed at 6 months for the global KOOS score, and each different subscale and for pain at walking ( = 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.

© The Author(s), 2022.

Address: Musculoskeletal Health Department, Nestle Research, EPFL Innovation Park, 1015 Lausanne, Switzerland.; Nestle Research, Vers-chez-les-Blanc, Lausanne, Switzerland.; Nestle Research, EPFL Innovation Park, Lausanne, Switzerland.; Artialis SA, CHU Sart-Tilman, Liège, Belgium.; Antwerpen Orthopedic Center, Antwerpen, Belgium.; CHC, Clinique Saint-Joseph, Liège, Belgium.; CHU UCL Namur, Site Mont-Godinne, Yvoir, Belgium.; Centre Hospitalier Régional de la Citadelle, Liège, Belgium.; Grand Hôpital de Charleroi, Charleroi, Belgium.; ZNA Middelheim, Antwerpen, Belgium.; ZNA Jan Palfijn, Merksem, Belgium.; Linus Pauling Preventie Centrum, Gent, Belgium.; Clinical Pharmacology Unit, ATC S.A., Liège, Belgium.; 2B Clinic, Wavre, Belgium.; CHU Sart-Tilman, Liège, Belgium.; 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.
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