That is not the peptide’s only potential benefit, however. Writing in Diabetes/Metabolism Research and Reviews, scientists also reported additional unexpected benefits of Pep19 (DIIADDEPLT), trademarked by Israel-based Proteimax Biotechnology. Not only did it reduce visceral fat by 25% in a clinical trial by the company, but participants also saw a 7-point reduction in systolic blood pressure.
“We had good preclinical rodent and dog data, so the findings on visceral fat and blood pressure were not a surprise,” study co-author Dr. Arnon Krongrad, MD, founding partner and chief strategy officer at Proteimax, told NutraIngredients.
The “real surprise” occurred between the animal experiments and the human clinical trial, Krongrad added. When some people took Pep19 before the trial, they experienced improvements in sleep quality, which encouraged researchers to explore sleep outcomes in the study.
“The sleep quality improvement is substantial,” said study co-author Dr. Prachi Singh, PhD, who heads the sleep program at the Pennington Biomedical Research Center in Baton Rouge, Louisiana.
Study participants saw a 35% improvement in subjectively measured sleep quality.
“We rarely see effects as profound as what we’ve seen with Pep19,” Dr. Singh added. “We rarely see people with poor sleep quality converting from poor to normal. This is exciting.”
Proteimax has notified the U.S. Food and Drug Administration regarding Pep19’s structure/function claims—how the nutrient or dietary ingredient affects the normal structure or function of the human body.
Described as smaller versions of proteins, peptides are a string of molecules that make up the “building blocks” of proteins. Pep19, which does not require a prescription, can appear in capsules, beverages and in food.
No adverse events
Weight-control interventions can show limited effectiveness to address obesity because of the complicated nature of the condition across adipose tissue, skeletal muscle and the brain.
“Recent studies have shown that the accumulation of visceral fat, rather than subcutaneous fat, is more strongly associated with increased cardiometabolic risk,” the researchers wrote. “Another factor contributing to obesity and related disorders is sleep. Experimental studies show that sleep deprivation contributes to obesity via increases in appetite, especially for foods high in calories and sugars, due to changes in hunger-regulating hormones such as ghrelin and leptin.”
A previous study funded by Proteimax found that Pep19 can reduce fat remodeling and fat loss with no adverse events in dogs. Pep19 has received the Generally Recognized as Safe/GRAS status and is commercially available a 5 mg dose.
According to Proteimax, several individuals who were taking 5 mg supplement capsules of Pep19 once a day at bedtime for at least 30 days “independently and spontaneously” reported weight loss and reduced waist circumference along with improved sleep quality, also without adverse events.
Study results
For this triple-blinded, placebo-controlled clinical trial, 24 obese participants (BMI between 30 and 35 kg/m2) were evaluated over 60 days after taking either 2 mg Pep19, 5 mg Pep19 or a placebo once daily at bedtime. Researchers gauged participants’ quality of life via questionnaires and evaluated weight loss, reduction of visceral fat measured by specialized X-ray and changes to waist, hip and chest.
“All the subjects in the 5 mg Pep19 group experienced a decrease in visceral fat, which was not observed on groups assigned to placebo or 2 mg Pep19,” the researchers noted. “Sleep quality was improved by both 2 mg and 5 mg doses of Pep19. These promising results suggest that Pep19 has successfully translated its remarkable effects from laboratory models to human applications, highlighting its innovative potential as a novelty to enhance overall health.”
Regarding fat loss, the researchers suggest that Pep19 works in people by the browning of white adipose tissue and remodeling through an increased activation of UCP1 gene expression, something they have shown to occur in cellular and animal models.
They noted that Pep19’s ability to reduce visceral fat may be an option for individuals unable to tolerate conventional therapies, including GLP-1s (semaglutide and tirzepatide), which can be associated with lean mass loss. The researchers indicated that the relatively small sample size in the study is a limitation but that given the significant role that visceral fat plays in the development of disease, there is a pressing need for further study and novel approaches to combat the issue.
“Current treatment strategies, including lifestyle interventions, bariatric surgery and GLP-1-based therapies, often prove ineffective over the long term for a significant portion of the population,” the researchers wrote. “This underscores the urgent need for novel therapeutic options to address this growing clinical challenge.”
Source: Diabetes/Metabolism Research and Reviews
doi: doi.org/10.1002/dmrr.70056
“Pep19: A Novel Approach for Reducing Visceral Fat and Improving Sleep Quality in Obese Adults—Results From an Early-Stage Clinical Trial”
Authors: Andrea S. Heimann et al.
