The study, which was coauthored by scientific consultant Dr. Jason Theodosakis MD, was on a biomarker of cartilage erosion called CTX-II. CTX-II, or C-terminal telopeptide, is a biomarker whose specificity to cartilage degradation was reaffirmed in a 2013 study in the journal Osteoarthritis and Cartilage. Its use in Stratum’s most recent study published in the journal Clinical Interventions in Aging as a marker in turnover in health joints subjected to exercise-induced stress was novel enough that the company has applied for a patent on the idea, Dr. Theodosakis told NutraIngredients-USA.
Study design looked at healthy joints
The use of the biomarker in this way achieves something that Dr. Theodosakis said has not been achieved before: Showing an improvement in cartilage status in healthy joints.
“When you exercise, your cartilage is metabolically active, too,” he said. “This particular biomarker for cartilage degradation is probably the most validated of all the biomarkers in joint health.”
The Stratum study with the novel employment of CTX-II measurements aimed to assess the performance of NEM on the healthy joints of post menopausal women. Exercise is an important part of maintaining a healthy lifestyle, especially for subjects in this group. But the occasional joint pain and stiffness that results from moderate exercise can sometimes dissuade people from sticking with a program.
The single center, randomized, double-blind, placebo-controlled study was designed to evaluate whether NEM would reduce cartilage turnover or alleviate joint pain or stiffness, either directly following exercise or 12 hours post-exercise, versus placebo. Stratum calls NEM a ‘triple acting’ ingredient in that it contains natural occurring hyaluronic acid, chondroitin and glucosamine, as well as three types of collagen, peptides and amino acids.
Sixty healthy, post-menopausal women, who reported no prior persistent joint pain, were randomly assigned to receive either oral NEM 500 mg (n = 30) or placebo (n = 30) once daily for two consecutive weeks while performing an exercise regimen (50 to 100 steps per leg) on alternating days. The primary endpoint for the study was any statistically significant reduction in exercise-induced cartilage turnover via the CTX-II measurements, versus placebo evaluated at one week and two weeks of treatment. Secondary endpoints were reductions in either exercise-induced joint pain or stiffness versus placebo, evaluated daily both immediately and 12 hours post-exercise (recovery) via participant questionnaire.
A once daily, small 500 mg dose of NEM rapidly improved recovery from exercise-induced joint pain (Day 8) and stiffness (Day 4), as well as significantly reduced discomfort immediately following exercise (stiffness, Day 7). Moreover, a substantial chondroprotective effect was demonstrated from NEM supplementation through a lasting decrease in the levels of CTX-II.
Building up a full picture via research
Dr Theodosakis, who is a longtime authority in joint health research, said he signed on as a scientific advisor to Stratum because he thought the ingredient itself was promising. And he said he believed the company was committed to building up a coherent suite of research to back its effects. Too often, he said, companies take shots in the dark when researching their ingredients.
“For so many companies, for most of the studies they do, they hire a CRO in India or somewhere and cross their fingers hoping there is some statistically relevant result in some pain parameter,” he said.
“At Stratum we built up a body of evidence with animal studies, pilot studies and open label studies. We knew this ingredient had a biological effect,” Dr. Theodosakis said.
Using a sensitive-enough measurement
Dr. Theodosakis said a big challenge in joint health research has been to show statistical relevance in the effects, especially as those effects relate to healthy people. Part of the issue has been that these studies often use MRIs or X ray images to measure differences in cartilage status pre- and post-intervention.
Those tools are usually too granular to give the best results, he said. By contrast, the CTX-II measurements are precise and they can help elucidate the chondroprotective effect of the ingredient that can be measured even in those subjects not experiencing particular joint discomfort post exercise.
“The analysis is very sensitive. MRI scans and X rays are very crude tools by comparison. We know that NEM has an effect on pain, but cartilage doesn’t have any nerve endings, so (without the CTX-II biomarker) it would be hard to show an effect if someone doesn’t have some pain to report. And I think it’s important to note that the results we saw in this study correlate very well with what we have seen in our earlier research,” he said.
Source: Clinical Interventions in Aging
“Beneficial effects of natural eggshell membrane versus placebo in exercise-induced joint pain, stiffness, and cartilage turnover in healthy, postmenopausal women"
19 February 2018 Volume 2018:13 Pages 285—295 DOI https://doi.org/10.2147/CIA.S153782
Authors: Ruff KJ, Morrison D, Duncan SA, Beck M, Aydogan C, Theodosakis, J