Short-term Intake of Calcium Fructoborate Improves WOMAC and McGill Scores and Beneficially Modulates Biomarkers Associated with Knee Osteoarthritis: A Pilot Clinical Double-blinded Placebo-controlled Study

¹Applied BioClinical, Inc., Irvine, CA, USA

²VDF FutureCeuticals, Inc, Momence, IL, USA,

³NutraClinical Inc., San Diego, CA, USA

*Corresponding Author

Boris Nemzer

Director of Research and Development

FutureCeuticals, Inc.

Momence, IL

USA

Email: bnemzer@vandrunen.com

Abstract

       Knee osteoarthritis (OA) is a common degenerative joint disease which contributes significantly to the burden of physical disability. Conventional management of OA mainly focuses on relief of symptoms using analgesics and non-steroidal anti-inflammatory drugs (NSAIDs). Some dietary supplements have shown some potency to reduce symptoms associated with OA conditions. Calcium Fructoborate (commercially marketed under the trade name FruiteX-B®), is a naturally occurring borate complex as first described by Patrick Brown [1]. For this study, FruiteX-B® was characterized by NMR and data from solid and liquid-state ¹¹B NMR have been obtained and compared against boric acid and fructose for quality purposes. In this study, FruiteX-B® was tested for fourteen days at a serving of 108 mg twice a day on subjects diagnosed with minor osteoarthritis conditions of the knees by CT scan. FruiteX-B® was well tolerated by all study subjects with no reports of adverse effect and resulted in several positive outcomes. On Day 14, WOMAC and McGill indexes were reduced by an average 29% and 14% respectively over Day 1 pre-ingestion values. Blood level of C-Reactive Protein (CRP) in 7 out of 10 subjects was found reduced up to 37% compared to Day 1 baseline levels. Interestingly, the study also showed that blood level of endogenous 1, 25(OH) vitamin D was increased more than 19% compared to baseline. However, differences in 25(OH) vitamin D were not observed. These results indicate that FruiteX-B® at a serving as low as 108mg twice a day provides significant benefits to people experiencing conditions associated with knee osteoarthritis. On the basis of these results, a larger clinical efficacy study is highly justified.

Keywords: Calcium Fructoborate (FruiteX-B®), knee osteoarthritis, WOMAC Index, McGill Index, C-Reactive Protein, vitamin D.

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