The mineral complex - marketed as FruiteX-B and manufactured exclusively by VDF Futureceuticals under US patent #5,962,049 - contains boron, calcium and fructose and could offer hope to osteoarthritis sufferers looking for alternatives to non-steroidal anti-inflammatory drugs (NSAIDs), claims the study’s authors.
“Due to potential serious side-effects of long term use of NSAIDs and recent safety concerns on COX-2 inhibitors, it is not surprising that osteoarthritis is the leading condition for which people seek and use alternative therapy.
“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.”
Study methodology
The two-week double-blind, placebo-controlled pilot study – published online ahead of print in the American Journal of Biomedical Sciences – involved 20 volunteers aged 44-65 with minor knee osteoarthritis as diagnosed by CT scan.
The volunteers were divided into two groups, one given placebo supplements (fructose) and the other given 108mg of FruiteX-B twice a day.
Blood was drawn before treatment and seven and 14 days after supplementation. Subjective testing measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the McGill pain questionnaire.
Blood levels of two biomarkers commonly associated with arthritis, C-Reactive Protein (CRP) and 1,25-Dihydroxy Vitamin D, were also measured.
Subjective pain scores decreased
WOMAC and McGill results indicated that subjects in the FruiteX-B group experienced significant improvements in pain, stiffness, and physical function after seven days of supplementation. By day 14, WOMAC and McGill scores improved by 29% and 14% respectively.
Meanwhile, CRP was reduced by up to 37% in seven out of 10 patients compared to baseline levels and blood levels of endogenous 1,25(OH) Vitamin D increased more than 19% on average compared to baseline.
Increased 1, 25[OH]2 D levels may play a positive role in bone and cartilage health in osteoarthritis subjects
However, differences in 25(OH) vitamin D were not observed, said the authors.
“In our study, FruiteX-B did not increase serum 25[OH]D levels after 7 and 14 days of intake. On the other hand, and unexpectedly, serum 1, 25[OH]2D levels in the FrxB group were elevated 16.4% and 19.9% at days seven and 14 respectively.
“The increase is relatively moderate but statistically significant. Although 25[OH]D is the major circulating form of vitamin D,1, 25[OH]2D levels can also be detected in blood at pictogram concentrations that are 1,000 times less than those of 25[OH]D.
“Produced mainly in the kidney, 1, 25[OH]2D is transported in blood and acts at a distance principally on intestinal cells to increase calcium absorption. Additionally, it also regulates differentiation and activation of chondrocytes in cartilage and osteoblasts and osteoclasts in bone.
“We speculate that increased 1, 25[OH]2 D levels may play a positive role in bone and cartilage health in osteoarthritis subjects. The mechanism of induction by FruiteX-B and whether a moderate increase of 1, 25[OH]2 D induced by FruiteX-B intake over a longer term may be beneficial for osteoarthritis conditions remain unclear at this point.
“Based on the results reported here, however, there is clear warrant for further investigation of the biological significance of FruiteX-B.”
Strong body of data
FutureCeuticals' vice president of sales Hartley Pond said: "The new study builds on our strong body of clinical data for FruiteX-B and underscores the product's capacity as a ‘fast acting’ supplement for improving flexibility and relieving discomfort associated with osteoarthritis.
"Perhaps the best testament to the product's appeal, subjects in the FruiteX-B group unanimously requested additional product at the conclusion of the study."
Osteoarthritis
Osteoarthritis affects nearly 27m individuals in the US alone, said the study’s authors.
“Knee osteoarthritis is the most common form with an estimated 12.1% of adults in the US suffering from associated pain and functional limitations.”
Current treatment regimens typically involve analgesics and NSAIDs (non-steroidal anti-inflammatory drugs) to relieve the symptoms, they added.
However, several nutraceuticals have been “intensively investigated as alternative approaches”, they noted.
“Several lines of evidence suggest that various nutritional supplements can improve osteoarthritis conditions, including antioxidant vitamins (C and E), non-antioxidant vitamins (D and B), glucosamine, chondroitin sulfates, trace elements (boron, selenium, zinc and copper), avocado-soybean unsaponifiables and fish oil.”
Source: American Journal of Biomedical Sciences, 2012, doi: 10.5099/aj120200111
‘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.’
Authors: Tania Reyes-Izquierdo, Boris Nemzer, Ana Elizabeth Gonzalez , Qing Zhou, Ruby Argumedo, Cynthia Shu, and Zb Pietrzkowski.