Significant results (p = 0.0105) were noted for the reduction in joint pain after 12 weeks, measured by joint pain K-VAS scores. The intervention group (20.8 ± 16.16 mm) had a greater mean reduction in joint pain compared to the placebo group (10.6 ± 17.58).
Consistent results for reduced joint pain was noted for another measurement tool known as Korean Western Ontario and McMaster Universities Index (K-WOMAC) (p = 0.0489). The intervention group had a lower joint pain score (−13.0 ± 13.62) than that of the placebo group (−5.5 ± 18.08).
However, it is key to note that the changes between two groups for reduced joint pain were not significant at week 6 (p = 0.0854).
As for joint function, significance was noted for the joint improvement assessment scores by both the investigator and participants in the intervention group (p < 0.05), indicating a greater degree of improvement at week six and 12.
The frequency of adverse events was also statistically significantly lower (p = 0.0455) for the intervention group (4%) than that of the placebo group (16%). The most common adverse events being gastrointestinal disorders that is common in both groups.
The results were based on a 12-week, randomised, double-blind, placebo-controlled trial, involving 93 participants with mild osteoarthritis on the knee or hip joint, between 21 December 2018 and 25 October 2019.
The study is funded by a Korean contract manufacturing firm NOVAREX and US ingredient firm Valensa International around their joint supplement known as FlexPro MD that entered the South Korean market around May this year.
The study wanted to compare the safety and efficacy of a supplement that combines krill oil, astaxanthin, and lower molecular weight hyaluronic acid to support joint health, among individuals with mild osteoarthritis.
FlexPro MD is a 600mg soft capsule containing Euphausia superba Antarctic krill oil, natural astaxanthin purified from Haematococcus pluvialis, and a proprietary hyaluronic acid produced from fermentation by Streptococcus zooepidemicus.
The researchers propose FlexPro MD supplementation as an effective adjunct treatment for osteoarthritis to complement the first-line treatment of medication, due to its limited side effects and clinically proven effectiveness of the ingredients.
The synergistic effect of the ingredients in the supplement accounted for the mechanism at work.
“The main components of FP-MD are krill oil, astaxanthin, and HA, which have shown beneficial effects on joint health in both preclinical and clinical studies. Synergistic effects of these three ingredients have been shown in animal models induced by lipopolysaccharide (LPS) and monosodium iodoacetate (MIA).”
All participants were randomly assigned into the intervention group (n = 48) and placebo group (n = 45). The placebo and intervention were designed to be inconspicuous in flavour and appearance.
Participants are instructed to take one capsule daily for 12 weeks, and advised to maintain their regular diet and physical activity levels during the study period. They were directed not to consume other dietary sources of krill oil, Haematococcus (astaxanthin), or sodium hyaluronate.
Participants were then measured at baseline, week 6 and week 12.
Aside from the joint pain measurement tools mentioned above, other efficacy measurements include Serum C-Reactive Protein (CRP) that looks at tissue inflammation, Urinary C-Telopeptide of Type II Collagen (CTX-11) that looks at degree of cartilage wear using blood or urine.
To assess for safety, clinical pathology tests such as blood and urine tests, vital measurements including pulse and blood pressure, physical measurements like weight, and results were taken to check for abnormal findings throughout the study.
Concluding the paper, the researchers said: “This randomized controlled trial demonstrated statistically significant improvements in K-VAS pain scores and K-WOMAC total and subscale scores for participants taking FP-MD compared with placebo after 12 weeks of supplementation, confirming that this functional food can effectively address joint pain, the main symptom of degenerative arthritis, and improve physical function.
“Based on these clinical trial results and previously reported long-term safety data, the unique formulation of FP-MD, including krill oil, astaxanthin, and HA, is suggested as a dietary supplement to potentially reduce joint pain and improve physical function in individuals with mild osteoarthritis.”
“A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of a Krill Oil, Astaxanthin, and Oral Hyaluronic Acid Complex on Joint Health in People with Mild Osteoarthritis”
Authors: Stephen Hill, W., et al.