Cranberry Supplement Industry Still Lacks Manufacturing Standardization, Driving Inconsistency in Effectiveness.

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Jun 22, 2023, 12:03 ET

While Studies Show What Makes a Cranberry Supplement Effective, Only Solv Wellness^® Uses That Guidance to Set Its Own Standard, with Ellura^®.

ATLANTA, June 22, 2023 /PRNewswire/ -- Solv Wellness is seeking to raise awareness of the basic science behind the mechanism of action for cranberry proanthocyanidins (PAC), and in doing so, help answer the question posed by a Cochrane review regarding standardization of cranberry PAC.

The basic science behind the mechanism of action of cranberry PAC demonstrates that only PAC from concentrated juice extract, like the PAC in Ellura, have bacteria-fighting power because they are 100% soluble. The PAC in other supplements come partially or entirely from the pomace (the skin, seeds, stems, and pulp), and PAC from pomace is not soluble. Solubility is what enables the body to absorb the PAC so it can enter the urine and block bacteria from sticking to the cellular walls.

In a recent fifth update to their original 1998 meta-analysis, Cochrane once again supports their original conclusion that products containing cranberry PAC can help prevent recurrent urinary tract infections (UTIs). In the same report, Cochrane also notes the industry suffers from lack of standardization—but stops short of saying what the standard should be.

While Cochrane has done a thorough job of reviewing published clinical studies, it's important to note that meta-analyses do not consider the basic science that proves mechanism of action and guides standardization. Other studies conducted by Amy Howell, PhD, from the Marucci Center for Blueberry and Cranberry Research at Rutgers University, and Bilal Chughtai, MD, urologist from Weill Cornell Medical College, have shown what the standard should be: 100% soluble PAC extracted from pure concentrated cranberry juice extract.

What is soluble PAC? Simply stated, soluble means the PAC is bioavailable. Solubility, or bioavailability, is key, because only soluble PAC exhibits strong bacterial anti-adhesion activity (AAA). This is the ability to inhibit uropathogenic (infectious) bacteria by binding to the parts of the bacteria that would otherwise adhere to the cellular walls of the urinary tract—type 1 pili and P fimbriae—interfering with the initial step of a urinary tract infection. When pathogenic bacteria can't stick to the urinary tract wall, they are flushed away with the urine stream in a normal and healthy manner.

Researchers from Weill Cornell Medical College and the Marucci Center for Blueberry and Cranberry Research at Rutgers University conducted two studies published in 2016 and 2021 that demonstrated soluble PAC is necessary for bacterial AAA.

In 2016, practicing urologist Bilal Chughtai, MD, and Dominique Thomas, BS, of the Weill Cornell Medical College, and research scientist Amy B. Howell, PhD, of the Marucci Center, studied 9 commercially available cranberry supplements containing PAC from different parts of the cranberry. All parts of the berry contain PAC, but only the PAC extracted from the concentrated juice of the cranberry are soluble. The PAC that come from the balance of the cranberry—the pulp, seeds, skin, and stems, also known as pomace—are not readily soluble, as noted in the American Herbal Pharmacopoeia.¹

In the study, published in the American Journal of Obstetrics and Gynecology², Chughtai, Thomas & Howell noted that the difference in PAC molecules across the supplements yielded a wide variability in bacterial AAA. While the researchers suspected solubility was the key factor, it wasn't until 2021, when they conducted a head-to-head comparison³ between Gikacran^®, a compound consisting entirely of soluble PAC extracted from only concentrated cranberry juice extract, and Pacran^®, a compound comprised entirely of cranberry pomace, that they had conclusive evidence to settle the verdict that PAC solubility is what drives AAA. With this study, healthcare providers now have guidance on how to advise their patients on cranberry PAC supplements for non-antibiotic UTI management.

So why hasn't 100% soluble PAC become the standard for cranberry supplement manufacturing? Because it's difficult and expensive to manufacture a supplement using PAC extracted from only the concentrated juice of cranberries, and in the United States, there isn't a governing body to mandate the standardization of food supplements.

Both studies by Howell et al. demonstrated a clear winner with respect to bacterial AAA: Ellura^® by Solv Wellness. Ellura exerts 16 to 20 times more AAA than the average cranberry supplement, and as much as 4 to 5 times more AAA than the most potent insoluble whole-berry product. "There is a large variability in the amount and anti-adhesion activity of PACs in commercially available cranberry products claiming to contain 36 mg PAC," said Howell. "AAA is not detectable in some cranberry supplements."

Ellura is the only commercially available product in the US that contains Gikacran, or 100% soluble PAC from concentrated cranberry juice extract, while others contain a blend of pomace and juice (e.g., whole-berry blends) or just pomace (e.g., cranberry powder).

"We tested placebo against 18 mg, 36 mg, and 72 mg to understand what the minimum efficacious dose is for Ellura. It turns out to be 36 mg of 100% soluble PAC," said Kevin Wade, co-founder and EVP of Clinical Development at Solv Wellness, LLC. "Standardization simply means we've defined what is effective, and we replicate that every single time. Ellura is standardized to contain 36 mg of Gikacran: 100% soluble PAC extracted from only concentrated cranberry juice extract."

Ellura is backed by 20+ clinical studies, 19 traditional medicine approvals worldwide, and a Drug Master File in Europe that was built based on U.S. Food and Drug Administration standards.

About Solv Wellness, LLC

Solv Wellness, LLC, formerly known as Trophikos, LLC, delivers products backed by science for often stigmatized female pelvic health conditions. For too long, women's needs at midlife and beyond have been underserved by the scientific and healthcare communities, and as a result, many women often dread much of what aging brings. Solv Wellness is committed to helping women stay optimistic about the future by providing meaningful solutions, backed by science, to the issues women experience at midlife and beyond. Solv Wellness is the company behind Ellura^®, Via™, and Māge™. Ellura is a clinically proven daily supplement for non-antibiotic management of recurrent urinary tract infections. Via is a vaginal moisturizer made with the highest-quality ingredients that help replenish moisture where women need it most. Māge is a state-of-the-art pre- and probiotic supplement that helps support the entire female pelvic triangle: the gut, vagina, and urinary tract.

For more information about Solv Wellness and its product offerings, visit solvwellness.com.
For scientific data, dosing information, and more, please visit hcp.solvwellness.com.

Contact Info:
Tamara Brown
SVP, Marketing
[email protected]
+1 (404) 618-4990

References:

¹Upton R., & Brendler T., (Eds.) (2016). American Herbal Pharmacopoeia: cranberry fruit (17, 20, 22, 39, 31).

²Chughtai B., Thomas D., & Howell A. (2016). Variability of commercial cranberry dietary supplements for the prevention of uropathogenic bacterial adhesion. American Journal of Obstetrics & Gynecology. 215(1), 122-123. doi: 10.1016/j.ajog.2016.03.046.

³Howell, A., Dreyfus, J.F., & Chughtai B. (2022). Differences in urinary bacterial anti-adhesion activity after intake of cranberry dietary supplements with soluble versus insoluble proanthocyanidins. Journal of Dietary Supplements, 19:5, 621-639. doi: 10.1080/19390211.2021.1908480.

Pacran^® is a registered trademark of Naturex^®. Solv Wellness is not connected to or endorsed by Naturex or Pacran in any way.
Ellura^® and Gikacran^® are registered trademarks of Pharmatoka^®.

Statements in this release have not been evaluated by the FDA.
These products are not intended to diagnose, treat, cure, or prevent any disease.

SOURCE Solv Wellness®