In a new randomized clinical trial of non-diabetic subjects older than 50 years, DolCas Biotech, LLC’s Bergacyn FF® demonstrated an ability to help reduce liver fat and body weight. This hallmark study follows previous investigation that supported Bergacyn’s liver-fat lowering effects in subjects with diabetes while providing extra cardioprotective support.
Non-alcoholic fatty liver (NAFL or steatosis) and the disease states it propagates currently affects upwards of two billion people worldwide — more people than in China and the US, combined. Although NAFLD can occur at any age, people are more likely to develop it as they age, with those in the age group of 40-60 years as a majority. It’s an epidemic people are only beginning to become aware of, as its lack of early symptoms and complicating role in many chronic diseases positions it to cripple economies.
NAFL is a lifestyle-linked process, driven by the excess consumption of fat, sugar and calories, as well as a sedentary lifestyle. Complications are extensive, affecting systems beyond the liver, including the heart and vascular systems and kidneys. It significantly impacts the onset and progression of diabetes. Weight loss and lifestyle change are the best ways to modulate the development and progression of fatty liver, but compliance is often an issue.
The study was conducted at the University Magna Grecia, Catanzaro, Italy, and published on August 11, 2020, in the journal Frontiers in Endocrinology. A total of 102 mildly hypercholesterolemic patients, age 35-70 and with liver steatosis, were enrolled in a double-blind, placebo controlled clinical trial and randomized to receive 600 mg/d of either Bergacyn FF or a maltodextrin-based placebo. As dietary changes and resultant weight loss are known to contribute to liver-fat regression, overweight and obese subjects in both groups were assigned the task of reducing their intake by 400-500 calories per day.
Results of the study, completed by 86 subjects, revealed that liver fat accumulation was reduced by 9% (p< 0.05) over the placebo group. Bergacyn FF also produced a significant positive factor in its potential to regress the progression of fatty liver, especially considering that the cutoffs for each stage differ by wide margins. Notably, in those subjects over 50 years of age, the reduction in liver fat was even more remarkable at 15% (p<0.05) greater than the placebo and was attributed solely to Bergacyn FF, and not the dietary changes. Subgroup analyses showed that Bergacyn FF produced more profound benefits over placebo not only for subjects older than 50, but for women and overweight/obese persons having an android “apple” shape phenotype.
“An unexpected outcome of the study was Bergacyn’s impact on weight loss,” remarks Dr. Shavon Jackson-Michel, Director of Medical & Scientific Affairs of DolCas Biotech. “The absolute difference made by Bergacyn FF for body weight reductions over placebo was approximately 4 lbs. The total weight loss in the Bergacyn FF group over 12 weeks fell just under 10 lbs. The new research supports the traditional wisdom of botanical synergism and how standardized ingredient formulations could be the best way forward for multifactorial processes such as NAFL.”
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