Previously, I’ve written articles for Vitamin Retailer about both the topical skin benefits and the ingestible joint health benefits of water-soluble eggshell membrane (WSEM). In this current article, I’m going to provide an update on human clinical research recently conducted on this fascinating material for joint health. I’ve chosen to do this because, after reviewing the research, I was impressed with the robust and well-designed nature of the studies. As with the previous article, let’s start this one with some background information about eggshell membrane.
Eggshell Membrane Background
Eggshell membrane is the thin membrane just under the shell that you sometimes have difficulty removing when you’re peeling a hard-boiled egg. WSEM is a unique water-soluble ingredient rich in the proteins collagen and elastin, a family of glycosaminoglycans that include chondroitin, glucosamine and hyaluronic acid, as well as the components desmosine and isodesmosine. Each of these components is native to eggshell membrane. Furthermore, eggshell membrane has been shown to increase cellular activity, raise elastin and collagen production, as well as prevent skin aging and reduce damage caused by UV (ultraviolet) light and inflammation.1
WSEM and Skin Benefits
An open-label pilot study2 was conducted to evaluate the effectiveness of 10 percent water soluble eggshell membrane (BiovaDerm, Biova) in a topical skin cream in reducing aged skin related winkles and its impact on sun damaged skin in 23 subjects who were evaluated three groups. Group 1 was instructed to apply study product for one week; Group 2 was instructed to apply the product for two weeks; and Group 3 was instructed to apply the product for four weeks. Results were that daily application of the water-soluble eggshell membrane demonstrated 28 percent reduction of deep wrinkles within four weeks in Group 3, 19 percent reduction of deep wrinkles within two weeks in Group 2, 30 percent reduction of deep wrinkles within one week in Group 1, and effectiveness of treatment continuing beyond two weeks from last product application.
Two additional studies on the topical use of WSEM were conducted, which I also discussed in a previous article.3 An open-label eight-week pilot study was conducted to evaluate the effects of 8 percent WSEM (BiovaDerm, Biova) in a topical skin cream on wrinkle reduction in 20 healthy females between the age of 45 and 65 years participated. The results were that topical use of a WSEM-containing facial cream for eight weeks resulted in a significant reduction of wrinkle depth (P<0.05). In addition, WSEM reduced the formation of reactive oxygen species by inflammatory cells and promoted more collagen and elastin production than untreated cells or cells treated with the control. The increase in collagen production was statistically significant (P<0.05).
A four-week dose dependence wrinkle reduction case study was conducted with six subjects using WSEM (BiovaDerm, Biova) at 5 percent and 10 percent inclusion levels, as well as a placebo formulation. Results were that WSEM showed greater wrinkle reduction at the 10 percent formula versus the 5 percent formula. The pilot results indicated that the subjects who used the 5 percent water-soluble eggshell membrane formula showed an average reduction in wrinkles of about 34 percent at four weeks and the subjects who used the 10 percent water soluble eggshell membrane showed an average reduction of about 48 percent at four weeks.
WSEM and Joint Health
BiovaFlex, a WSEM ingredient (450 mg/day) manufactured by Biova, LLC, was evaluated in an open-label, six-week pilot study for safety and efficacy in the treatment of musculoskeletal pain and flexibility in 42 subjects with history of arthritic type joint pain or connective tissue disorder with a reduced range of motion. Results were that pain symptoms were reduced 8.25 percent from baseline within seven days and 23.77 percent from baseline within 10 days. The average WOMAC value across all subjects fell from 4.61 (baseline) to 3.69 (study end), a reduction of 0.97 or 20.78 percent. (P<0.0001).
A randomized, double-blind, placebo-controlled crossover study,4 including two four-week periods of placebo and 450 mg/day WSEM (BiovaFlex, Biova) consumption separated by a four-week washout period, evaluated the effects on joint function in an otherwise healthy population of 25 study participants experiencing chronic pain. The results showed that consumption of WSEM was associated with improved range of motion (ROM) for neck, spine, hips and knees, with ROM for the neck and right knee being significantly improved during WSEM consumption compared to placebo (P < 0.05). Physical activity levels and physical energy levels were significantly higher after WSEM than after placebo consumption (P < 0.05 Subgroup analysis showed rapid improvement of lower back pain after five days of WSEM consumption compared to placebo consumption (P < 0.05) in subjects who participated in the study during the winter season.
New Research on WSEM and Skin Benefits
This new study on WSEM and skin benefits was significantly different than those previously cited. The first major difference is that that WSEM was ingested as a dietary supplement, rather than applied topically to the skin. In addition, this randomized, double-blind placebo-controlled study5 had a more robust population of 88 subjects who were randomized evenly (n=44 in each group) to 450 mg/day WSEM (BiovaBio, Biova) or placebo for 12 weeks. The aim of this study to objectively and subjectively evaluate the impacts of WSEM as compared to placebo on the appearances of hair, skin and nails in healthy middle-aged adults (35-65 years of age). Outcome tests included TrichoScan HD (hair), Canfield Visia-CR with the Vaestro Wrinkle Analysis Algorithm (skin), modified FACE-Q (skin), and anchored Likert Scales (nails). Results were that WSEM was associated with a significant improvement in facial skin appearance in crow’s feet in four weeks and a significant change in the depth of wrinkles at week 12 (P = 0.0089), but not for the placebo group.
Likewise, there was a significant improvement in skin tone in eight weeks, with significant impact on hair thickness (about 18 percent over placebo at week 12), reduction in hair breakage and improvement in hair growth at four, eight and 12 weeks. There were no observed subjective improvements for nails. The results of this study demonstrated that oral supplementation of 450 mg/d WSEM for 12 weeks is associated with improvement in the appearance of facial skin and hair, just as previous research demonstrated that topical application of WSEM was effective for skin appearance.
New Research on WSEM and Joint Health
As with the new skin study, this new double-blind, placebo-controlled clinical trial6 on joint health was equally robust with a population of 88 subjects with knee osteoarthritis who were randomized into two groups of 450 mg/day WSEM (BiovaFlex, Biova) (n = 44) or placebo (n = 44). The purpose of this study was to assess the safety and efficacy of a WSEM on knee function, mobility and general health and well-being. Outcomes were assessed periodically over 12 weeks, including the Western Ontario McMaster Osteoarthritis Index (WOMAC), the six-minute walk test (6MWT), knee ROM testing and safety. The results were impressive. Compared to baseline, those subjects who initially performed most poorly benefited the greatest from the WSEM by day five in the 6MWT, with the rest of the population showing significant improvement over placebo by week 12. The normalized WOMAC Stiffness score was also significantly improved over placebo by day 5 (P <0 .05). WSEM was also found to be safe in this study. In conclusion, daily consumption of WSEM significantly enhanced average individual physical capacity (walking distance and ability), reduced stiffness by the fifth day of supplementation with the greatest benefit seen by the most compromised individuals and was maintained more than 12 weeks.
The WSEM and placebo subjects were assessed at baseline on the distance walked for the six-minute walk test. This chart shows the WSEM subjects in a typical bell curve distribution with subjects at both the slow end of the spectrum walking less than a tenth of a mile in six minutes and those who were at the very high end of the chart walking over four tenths of a mile in six minutes. Subjects were again assessed at five days and results showed that the WSEM subjects who were most compromised, the slowest performers, improved significantly within five days doubling their distance from less than a tenth of a mile to almost two tenths of a mile. This indicates that performance for the most compromised WSEM subjects improved significantly in five days and those subjects that were not as compromised did not improve as much. Therefore, the poorer the performance, the greater the benefit observed with WSEM. Measurements taken at the end of the study showed that the slowest performers maintained the improved performance over the 12-week period. These results concur with a 2005 Merck study7 of NSAIDs (nonsteroidal anti-inflammatory drugs) use in subjects with OA of the knee.
Conclusion
New human research has demonstrated that WSEM materials (BiovaBio and BiovaFlex, Biova) are effective in improvement in the appearance of facial skin and hair, and in relieving OA (osteoarthritis) symptoms and increasing mobility, the treatment of arthritic type joint pain or connective tissue disorder. In the case of BiovaFlex, significant improvements in OA parameters were seen in only five days. Furthermore, these new studies were robust with 88 subjects each in a randomized, double-blind, placebo-controlled design. In addition, the demonstrated benefits were achieved with a single daily dose of 450 mg. VR
References:
1 Candilish JK, Scougall RK. L-5-hydroxylysine as a constituent of the shell membrane of the hen’s egg. Int J Protein Res. 1969;1:299-306.
2 FINAL REPORT. Human Clinical Safety and Efficacy Pilot Study BiovaDerm: A Topical Egg Shell Membrane Ingredient for Aged or Sun Damaged Skin. Clinicians and study personnel at: Science, Toxicology & Technology—Product Research; July 7, 2009:23 pgs.
3 Bruno G. Water-soluble Eggshell Membrane: Topical Benefits for Skin. Vitamin Retailer. 2018; September: 68-70.
4 Jensen GS, Lenninger MR, Beaman JL, Taylor R, Benson KF. Support of Joint Function, Range of Motion, and Physical Activity Levels by Consumption of a Water-Soluble Egg Membrane Hydrolyzate. J Med Food. 2015 Sep;18(9):1042-8.
5 Kalman DS, Hewlings S. The effect of oral hydrolyzed eggshell membrane on the appearance of hair, skin, and nails in healthy middle-aged adults: A randomized double-blind placebo-controlled clinical trial. J. Cosmet Dermatol. 2020 Jan;00:1–10.
6 Hewlings S, Kalman D, Schneider LV. A Randomized, Double-Blind, Placebo-Controlled, Prospective Clinical Trial Evaluating Water-Soluble Chicken Eggshell Membrane for Improvement in Joint Health in Adults with Knee Osteoarthritis. J Med Food. 2019 Sep;22(9):875-884.
7 Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33.
Gene Bruno, MS, MHS, the dean of academics for Huntington University of Health Sciences, is a nutritionist, herbalist, writer and educator. For more than 30 years he has educated and trained natural product retailers and health care professionals, has researched and formulated natural products for dozens of dietary supplement companies, and has written articles on nutrition, herbal medicine, nutraceuticals and integrative health issues for trade, consumer magazines and peer-reviewed publications. He can be reached at [email protected].
