A Double-Blind Randomized Placebo Controlled Parallel Group Study Demonstrates Analgesic Effects of Sheanut Oil Extract [BSP-201] in Exercise Induced Muscle Tenderness

Objectives: Oral sheanut oil extract [BSP-201] is an active bio-complex obtained from a fraction of sheanut oil with approximately 50 to 70 percent unsaponifiables that reduced dose-dependently interleukin-6 production from the rat pristine-induced peritonitis exudates cells. The primary objective of this placebo-controlled study was to investigate the effects of BSP-201 on development of post-exercise muscle tenderness. Methods: Three grams of BSP-201 or placebo was given orally daily in 4 750 mg soft gel capsules for 22 days to 20 healthy men aged, 26 0.61 years [mean standard deviation] in a double-blind, randomized control study. Subjects carried out an intensive eccentric exercise of the first dorsal interosseous muscle of the left hand on a standardized hand exerciser on the day 14. Muscle tenderness was tested on days 0, 14 [before exercise], 14 [immediately after exercise], 15 [one day after exercise], 16 [two days after exercise with maximal tenderness], and 22 [eight days after exercise] by pressure algometry. Results: Muscle tenderness on days 0 and 14 [before exercise] was not different in the two groups. Muscle tenderness was significantly reduced [24.3 4.8 mm] in the group that consumed BSP-201 as compared to the placebo group [47.4 6.5 mm] at day 14 [immediately after, P 0.01] and at day 16 [P 0.04] after the exercise. None of the participants reported any adverse effects. Conclusion: Oral administration of BSP-201 reduces muscle tenderness after eccentric exercise presumably by inhibiting the muscle inflammatory processes via a reduction of pro-inflammatory cytokine interleukin-6.