Background: Nutraceuticals have emerged as promising alternatives to conventional pharmacological treatments for managing joint pain and low-grade inflammation in physically active individuals. However, few clinical studies have evaluated the combined metabolic, inflammatory, and neuroendocrine effects of multi-ingredient supplements. This study aimed to evaluate the effects of Flector Softgel FS Integratore, a multi-component food supplement, on joint pain, inflammatory markers, metabolic health, and orexin-A levels in physically active adults. Methods: In this randomized, controlled, low-intervention study, 25 adult participants (aged 30-60 years and amateur athletes engaging in at least 3 sessions/week of moderate physical activity) were assigned to either a treatment group (n = 15 received Flector Softgel FS for 14 days) or a placebo group (n = 10). The supplement contained 500 mg of Cannabis sativa seed oil (THC-free), 250 mg of Boswellia serrata extract, 250 mg of fish oil, 160 mg of omega-3 fatty acids, and 0.6 mg of undenatured type II collagen (UC-II). Pain was assessed using the Visual Analog Scale (VAS). Metabolic parameters, inflammatory cytokines (IL-6, IL-8, TNF-α, IFN-γ, and IL-10), and serum orexin-A levels were measured before and after the intervention. Results: Compared with the placebo, the treatment group showed a significant reduction in VAS scores (p < 0.001), as well as improvements in BMI, insulin, and lipid profiles, and a decrease in pro-inflammatory cytokines (IL-6, IL-8, TNF-α, and IFN-γ). A reduction in orexin-A levels was also observed in the treatment group (p < 0.001), with a positive correlation between orexin-A and perceived pain. No adverse effects were reported. Conclusions: Flector Softgel FS Integratore may be effective in reducing joint pain and systemic inflammation while supporting metabolic health in active adults. These effects may involve indirect modulation of orexin-A, though the exact mechanisms remain to be clarified. Despite the promising results, conclusions regarding efficacy in comparison with NSAIDs should be approached with caution in the absence of a pharmacological control group. Further studies with larger samples and a longer duration are needed.
The Potential Benefits of a Novel Food Supplement Based on Cannabis Sativa, Boswellia, and Fish Oil for Pain and Inflammation in Physical Activity: Unraveling the Role of Orexin-A Modulation
Di Maio, Girolamo;Polito, Rita;Moscatelli, Fiorenzo;
2025-01-01
Abstract
Background: Nutraceuticals have emerged as promising alternatives to conventional pharmacological treatments for managing joint pain and low-grade inflammation in physically active individuals. However, few clinical studies have evaluated the combined metabolic, inflammatory, and neuroendocrine effects of multi-ingredient supplements. This study aimed to evaluate the effects of Flector Softgel FS Integratore, a multi-component food supplement, on joint pain, inflammatory markers, metabolic health, and orexin-A levels in physically active adults. Methods: In this randomized, controlled, low-intervention study, 25 adult participants (aged 30-60 years and amateur athletes engaging in at least 3 sessions/week of moderate physical activity) were assigned to either a treatment group (n = 15 received Flector Softgel FS for 14 days) or a placebo group (n = 10). The supplement contained 500 mg of Cannabis sativa seed oil (THC-free), 250 mg of Boswellia serrata extract, 250 mg of fish oil, 160 mg of omega-3 fatty acids, and 0.6 mg of undenatured type II collagen (UC-II). Pain was assessed using the Visual Analog Scale (VAS). Metabolic parameters, inflammatory cytokines (IL-6, IL-8, TNF-α, IFN-γ, and IL-10), and serum orexin-A levels were measured before and after the intervention. Results: Compared with the placebo, the treatment group showed a significant reduction in VAS scores (p < 0.001), as well as improvements in BMI, insulin, and lipid profiles, and a decrease in pro-inflammatory cytokines (IL-6, IL-8, TNF-α, and IFN-γ). A reduction in orexin-A levels was also observed in the treatment group (p < 0.001), with a positive correlation between orexin-A and perceived pain. No adverse effects were reported. Conclusions: Flector Softgel FS Integratore may be effective in reducing joint pain and systemic inflammation while supporting metabolic health in active adults. These effects may involve indirect modulation of orexin-A, though the exact mechanisms remain to be clarified. Despite the promising results, conclusions regarding efficacy in comparison with NSAIDs should be approached with caution in the absence of a pharmacological control group. Further studies with larger samples and a longer duration are needed.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
