Analysis of Effectiveness of a Supplement Combining Harpagophytum procumbens, Zingiber officinale and Bixa orellana in Healthy Recreational Runners with Self-Reported Knee Pain: A Pilot, Randomized, Triple-Blind, Placebo-Controlled Trial

Marcela González-Gross, Carlos Quesada-González, Javier Rueda, Manuel Sillero-Quintana, Nicolas Issaly, Angel Enrique Díaz, Eva Gesteiro, David Escobar-Toledo, Rafael Torres-Peralta, Marc Roller, Amelia Guadalupe-Grau, Marcela González-Gross, Carlos Quesada-González, Javier Rueda, Manuel Sillero-Quintana, Nicolas Issaly, Angel Enrique Díaz, Eva Gesteiro, David Escobar-Toledo, Rafael Torres-Peralta, Marc Roller, Amelia Guadalupe-Grau

Abstract

Recreational running (RR) is becoming a popular way to increase physical activity for improving health, together with a higher incidence of knee injuries. The aim was to analyze the effect of a four-week supplementation with a mixture of Harpagophytum procumbens, Zingiber officinale and Bixa orellana on males, middle-aged, RR with an undiagnosed knee discomfort. A randomized triple-blind placebo-control trial was conducted among male RR aged 40-60 years suffering from self-declared knee discomfort after training. Participants were assigned to supplementation (2 g/day in 6 doses; n = 13; intervention group (IG)) or matched placebo (n = 15; control group (CG)) for 4 weeks. At pre- and post-intervention, assessment of routine blood biomarkers, body composition, running biomechanics and body temperature was performed using standardized procedures. Machine learning (ML) techniques were used to classify whether subjects belonged to IG or CG. ML model was able to correctly classify individuals as IG or CG with a median accuracy of 0.857. Leg fat mass decreased significantly (p = 0.037) and a deeper reduction in knee thermograms was observed in IG (p < 0.05). Safety evaluation revealed no significant differences in the rest of parameters studied. Subjects belonging to IG or CG are clearly differentiated, pointing into an effect of the supplement of ameliorating inflammation.

Trial registration: ClinicalTrials.gov NCT04150211.

Keywords: Bixa orellana; Harpagophytum procumbens; Zingiber officinale; biomechanical phenomena; knee joint inflammation; recreational runners; thermography.

Conflict of interest statement

M.R. and N.I. were employed by Natural Origins during the conduct of this study. Natural Origins is involved in the research and development of Exten(d). Therefore, Natural Origins has a commercial interest in this publication. Other authors have nothing to report.

Figures

Figure 1
Figure 1
Schematic view of the study.
Figure 2
Figure 2
Schematic view of the evening protocol.
Figure 3
Figure 3
Thermographic imaging. (a) Front and (b) back.
Figure 4
Figure 4
Skin temperature (°C) before (Pre) and after (Post) administration of 2 g of Exten(d) for 30 days to volunteers compared to placebo. IRT0 = basal round; IRT1 = after acclimation to room temperature; IRT2 = after first biomechanical running test; IRT3 = shortly before incremental test to exhaustion; IRT4 = immediately post-incremental exercise test to exhaustion; IRT5 = after cooling down. * p < 0.05; a = intragroup; b = intergroup (Pre).

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