Supplementation with Curcugen® from Dolcas Biotech delivered clinically significant improvements in knee pain and performance-based tests in a randomized, double-blind, placebo-controlled study

LANDING, N.J., Jan. 19, 2022 /PRNewswire/ -- Curcugen® from Dolcas Biotech, LLC, shows positive application in osteoarthritis and reduces analgesic use, a new study demonstrates. Curcugen is a clean, dispersible, highly concentrated, clinically studied curcumin ingredient, fully derived from a turmeric base with a high curcuminoid concentration (50%).

In a recently published peer-reviewed article, "An Investigation into the Effects of a Curcumin Extract (Curcugen®) on Osteoarthritis Pain of the Knee: A Randomized, Double-Blind, Placebo-Controlled Study," Dolcas Biotech has validated both joint support and healthy aging claims for its unique turmeric extract, Curcugen.

The research, published online in Nutrients on 23 December 2021[1], evaluated both subjective and objective endpoints — including pain scales and performance tests — in 101 subjects of both genders averaging 58 years of age. During the 8-week clinical trial, Curcugen was dosed at 500 mg twice daily with the acceptable use of traditional pain relievers as a rescue option on an as-needed basis.

Osteoarthritis (OA) is a disease of the whole joint comprising structural alterations in the articular cartilage, subchondral bone, ligaments, capsule, synovial membrane and periarticular muscles. Various preparations of curcuminoids have been evaluated in the context of OA and concluded to be helpful. However, concerns regarding protocol design and study populations have sown seeds of uncertainty. This study has differentially included functional assessments of joint performance to reduce evaluation biases and examined an ethnically diverse population in Australia.

For example, eligible subjects were confirmed to have a previous diagnosis of knee OA and a pain rating of at least 6 out of 10 (10 being the worst). Outcome measures included the Knee Injury and Osteoarthritis Outcome Score (KOOS), knee pain ratings, Japanese Orthopaedic Association Score for Osteoarthritic Knees (JOA), PROMIS–29 and performance-based testing.

At the end of the trial, the KOOS data showed a statistically significant improvement in the Curcugen group, compared with those taking a placebo, as did the results of the observer-led JOA assessment for total scores. Also of note, 19 of the 51 subjects in the Curcugen group had decreased their medication at the endpoint, whereas only six in the placebo group were able to do the same. Curcugen was well tolerated and no serious adverse events were reported by participants.

Principal investigator Adrian L. Lopresti, PhD, comments: "The results of this trial identified a standard level of translatability to larger audiences, which compares very well with other studies in the area of knee joint pain. The data that has been obtained for Curcugen identify it as a promising, well-tolerated and naturally derived joint-support option.

Curcugen is DolCas' full spectrum highly bioavailable curcuminoid ingredient that tips its hat to both zero-waste and ecofriendly initiatives. The sustainably sourced, agrofueled manufacturing process generates a clean, food-grade byproduct that is upcycled into a base ingredient for local culinary use.

"In contrast to certain generic curcumin products, Curcugen's unique formulation preserves the original complex of curcuminoids, essential oils and polar resins within a natural matrix," notes Dr Shavon Jackson-Michel, Director of Medical and Scientific Affairs for DolCas Biotech. "These naturally occurring constituents synergistically increase curcumin bioavailability and, as supported by this trial, its efficacy in the treatment of OA of the knee."

She adds: "The point I find most interesting in this study is its evaluation of the Minimal Clinical Important Difference (MCID). It's an outcome that's considered to be meaningful for the subjects themselves and, as such, is both clinically important and elevates the results above simple statistical significance." An average MCID of 33% was recorded for subjects taking Curcugen compared with 19% in the placebo group.  

Curcugen recently obtained Self-Affirmed GRAS status for use in foods and beverages, such as bars and smoothies. Its palate-friendly taste profile also sets it apart in these food and drink preparations, as it is very easy to adapt to formulations of any kind. The product is the only one in the market to maintain the natural ratio of native curcuminoid compounds, curcumin, demethoxycurcumin (DMC) and bisdemethoxycurcumin (BDMC), underscoring its closeness to the turmeric rhizome and its unmatched ability to complement food and beverage-based formats.

[1] https://www.mdpi.com/2072-6643/14/1/41

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SOURCE DolCas Biotech

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