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Background: The demand for safe and efficacious botanical formulations to increase muscle mass, strength, and stamina is increasing among athletes and the general population. The nutraceutical supplements of medicinal plant origin exert minimal health concern. Objective: This randomized, double-blind, placebo-controlled study was aimed to evaluate the ergogenic potential of a proprietary, standardized formulation (LI12542F6) of Sphaeranthus indicus flower head and Mangifera indica stem bark extracts. Methods: Forty male participants 18-40 years of age were assigned to receive either a placebo (n = 20) or 650 mg/day LI12542F6 (n = 20) for 56 days. All participants performed a fixed set of resistance exercises during the intervention. The primary endpoint was the change from baseline muscle strength, assessed by one-repetition maximum (1-RM) bench and leg presses, and handgrip strength. The secondary endpoints included cable pull-down repetitions, time to exhaustion on a treadmill, mid-upper arm circumference (MUAC), body composition using dual-energy x-ray absorptiometry (DEXA), and free testosterone and cortisol levels in serum. Results: Fifty-six days supplementation of LI12542F6 significantly improved baseline bench press (P < 0.0001), leg press (P < 0.0001), handgrip strength (P < 0.0006), number of repetitions (P < 0.0001), and time to exhaustion (P < 0.0008), compared to placebo. Post-trial, the LI12542F6 group also showed significantly increased MUAC and improved body composition and serum hormone levels. The participants' hematology, clinical chemistry, and vital signs were within the normal range. No adverse events were observed. Conclusion: This study demonstrates that LI12542F6 supplementation significantly increases muscle strength and size and improves endurance in healthy men. Also, LI12542F6 is well-tolerated by the participants.
RESUMO
BACKGROUND AND OBJECTIVE: Aflapin®, also known as AprèsFlex® was developed as an enhanced bioavailable extract of Boswellia serrata gum resin, standardized to 20% 3-O-acetyl-11-keto-ß-boswellic acid. This randomized, double-blind, placebo-controlled clinical trial confirms the efficacy of Aflapin in ameliorating the symptoms of osteoarthritis (OA) of the knee. METHODS: Based on the inclusion/exclusion criteria of the American College of Rheumatology, seventy subjects were recruited and randomized into Placebo (n = 35) and Aflapin (n = 35) groups. Subjects received either 100 mg Aflapin or a placebo for 30 days. All subjects were evaluated for pain and physical function using the standard tools i.e., Visual Analog Scale (VAS), Lequesne Functional Index (LFI), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the baseline (Day 0), 5, and 30 days of treatment. Additionally, several inflammatory and cartilage biomarkers, including matrix metalloproteinase-3 (MMP-3), tumor necrosis factor-α (TNFα), high-sensitive C-reactive protein (hsCRP), Cartilage Oligomeric Matrix Protein (COMP), and collagen type II cleavage (C2C) were evaluated. Total blood chemistry analyses were conducted to affirm the safety of Aflapin. RESULTS: Sixty-seven subjects completed the study. Aflapin conferred significant improvements in pain scores as early as five days of treatment. Post-trial, VAS, LFI, WOMAC pain, WOMAC stiffness, WOMAC function, and total WOMAC scores decreased in the Aflapin group by 45%, 40.9%, 44.4%, 66.3%, 44.4%, and 48%, respectively. Aflapin supplementation also reduced circulating MMP-3, TNFα, hsCRP, and C2C. CONCLUSION: This investigation affirms that Aflapin is clinically efficacious, fast-acting, and safe in the management of osteoarthritis. No significant adverse effects were observed.