Shilajit extract reduces oxidative stress, inflammation, and bone loss to dose-dependently preserve bone mineral density in postmenopausal women with osteopenia: A randomized, double-blind, placebo-controlled trial.

BACKGROUND

Accelerated bone loss associated with aging and estrogen withdrawal is mediated in part by increased oxidative stress and inflammation.

OBJECTIVE

Investigate dietary supplementation with a standardized aqueous extract of shilajit with clinically demonstrated antioxidant, anti-inflammatory, and collagen-promoting activity on attenuating bone loss in postmenopausal women with osteopenia.

DESIGN

Sixty postmenopausal women aged 45 - 65 years with osteopenia were randomized to receive 1 of 3 treatments daily for 48 weeks: (1) placebo, (2) 250 mg shilajit extract, or (3) 500 mg shilajit extract. Bone mineral density (BMD) of the lumbar spine (LS) and femoral neck (FN) were measured at weeks 0, 24, and 48, and circulating markers of bone turnover (CTX-1, BALP, RANKL, OPG), oxidative stress (MDA, GSH), and inflammation (hsCRP) at weeks 0, 12, 24, and 48.

RESULTS

BMD of both the LS and FN progressively decreased in women receiving placebo but was dose-dependently attenuated with shilajit extract supplementation, resulting in significantly increased percentage changes from baseline in BMD at 24- and 48-weeks in both supplemented groups compared to placebo (p < 0.001). CTX-1, BALP, and RANKL decreased, whereas OPG increased, in both groups supplemented with the shilajit extract, but not in the placebo group, resulting in significantly decreased or increased percentage changes from baseline, respectively. MDA was significantly decreased (p < 0.001) and GSH was significantly increased (p < 0.001) in both supplemented groups compared to placebo from week 12 for the duration of the study. Progressive reductions in hsCRP were observed in both supplemented groups, resulting in significantly decreased percentage changes from baseline in supplemented women compared to placebo (p < 0.001).

CONCLUSION

Daily supplementation with this shilajit extract supports BMD in postmenopausal women with osteopenia in part by attenuating the increased bone turnover, inflammation and oxidative stress that coincides with estrogen deficiency in this population at increased risk for osteoporosis and bone fractures.