Food and Nutrition Research has published a third human clinical trial confirming improved joint comfort and enhancing performance and physical improvements
American pharmaceutical company NXT USA has announced the publication of the third human clinical study confirming TamaFlex with joint and physical benefits.
This new study, published in Food and Nutrition Research 67 (2023), also shows that TamaFlex, a standardized synergistic anti-inflammatory botanical formulation containing Tamarindus indica seed extract and Curcuma longa rhizome extract at a 2:1 ratio, improved joint comfort and function, aerobic capacity, and lower body strength of participants, with biomarkers objectively showing physiological changes.
“This study is especially relevant for our TamaFlex ingredient,” said Eric Anderson, Managing Director, NXT USA. “Where our previous studies focused on identifying that joint relief was fast-acting and long-lasting, this third study provides concrete data supporting our novel approach to joint health and the impact it has on improving participants’ quality of life and physical capabilities.
“The study is large and comprehensive, with physician assessment, physical tests and biomarkers providing subjective and objective evidence of efficacy. This is truly unique,” he added.
The 30-day randomised, double-blind, placebo-controlled clinical study assessed the efficacy of the herbal composition in 150 subjects (males and females aged 40-70 years) with mild to moderate knee osteoarthritis (OA) divided into three groups: placebo, 250mg TamaFlex, and 1000mg active comparator of Boswellia and Curcumin 1000mg.
The primary endpoint was a change from baseline to the end of the study period in total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score. Secondary endpoints were changes from baseline to the end of the study period in WOMAC Pain, Stiffness, and Physical Function Scores; 30-Second Chair Test; Six-Minute Walk Test; Stair Climb Test; VAS Score; LFI Score; Primary Knee Flexion (range of motion); High-sensitivity C-reactive protein (hsCRP, biomarker); Urinary C-terminal cross-linked telopeptide of type II collagen (uCTX-II, biomarker). The study also evaluated the safety and tolerability in the study participants by monitoring the vital parameters, clinical chemistry measures, and adverse events (if any).
The study demonstrates the potential of TamaFlex in improving joint health by reducing pain, joint stiffness, and improving physical function in subjects with mild to moderate knee OA
According to the authors: “The study demonstrates the potential of TamaFlex in improving joint health by reducing pain, joint stiffness, and improving physical function in subjects with mild to moderate knee OA. After 30 days of supplementation with 250 mg of TamaFlex, participants showed a significant reduction in pain, joint stiffness, and improvement in their physical function. Further, significant reductions in ‘VAS pain’ scores following the 30-day supplementation of TamaFlex indicate the improvement in joint comfort. In line with ‘VAS pain’ scores and scores of WOMAC subscales, the total WOMAC score was significantly improved from day 5 itself. Improvements in LFI scores indicate the improvements in joint flexibility of the participants in the TamaFlex group.”
The authors identified that TamaFlex supplementation also improved the aerobic capacity and endurance of the knee OA subjects as measured by the absolute distance walked by subjects in Six-Minute Walk Test. Following the 30-day supplementation, the participants' lower body strength, power, and physical function improved significantly as witnessed by a significant increase in mean time covered during Stair Climb Test. Further, TamaFlex-supplemented subjects showed increased repetitions in the Chair Stand Test in 30 sec.
Finally, in addition to noting no intervention-related adverse events during the study, at the end of 30 days of supplementation, normalized uCTX-II levels were significantly lower in the TamaFlex group, compared to baseline, but the levels increased in the placebo group. While the active comparator arm at 1000mg showed some benefits, the onset took significantly longer and was not nearly as successful as TamaFlex at 250mg.
“This study affirms the potent and fast benefits of TamaFlex supporting joint health,” Anderson commented. “What is also important is that in addition to physician assessment, this trial shows performance benefits with participants being able to walk farther, faster, and ascend and descend stairs with more alacrity. And the biomarkers show physiological changes are actually happening, which is purely objective.”