Clinical trial NCT06359327: Effect of Consumption of Pep19 on Quality of Life
Official title: Effect of Consumption of Pep19 on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Obesity
Sleep Quality
Keywords: Peptide
Body weight managment
Sleep
Lead sponsor: Proteimax Biotechnology Israel LTD
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods. Pep19 has no effect on the brain, heart, pancreas or skeletal muscle. It is highly purified, not allergenic or mutagenic, and free of microbes, metals and other contaminants. Preliminary, open-label, uncontrolled studies have shown that Pep19 is well tolerated in rodents, dogs, and humans. This placebo-controlled study will evaluate the effects of two doses of Pep19™ -- 2 mg and 5 mg - on quality of life and sleep quality in obese subjects.

Detailed description: Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. Obesity is a complex, multifactorial disease that develops from the interaction of genetic, metabolic, social, behavioral, and cultural factors. Numerous studies have demonstrated that obese persons experience significant impairments in quality of life as a result of their obesity, with greater impairments associated with greater degrees of obesity. Weight loss has been shown to improve quality of life in obese persons undergoing a variety of treatments.

Quality of life (QoL) is a concept which aims to capture the well-being. For example, common facets of QoL include personal health (physical, mental, and spiritual), relationships, education status, work environment, social status, wealth, a sense of security and safety, freedom, autonomy in decision-making, social-belonging and their physical surroundings. The World Health Organization explains QoL as a subjective evaluation of one's perception of their reality relative to their goals as observed through the lens of their culture and value system. Therefore, if the individual is feeling that its clothes are fitting better and that he is more motivate to lose weight, it could be considered an improvement of QoL.

In this study we will access QoL in two different ways. Using the S-12 questionnaire to assess physical and mental health, in an indirect way, as this is the view that the subject has of himself. And we will also use biomarkers (weight loss, glucose and insulin levels and so on) to obtain subject-independent data on the physiological changes that could be a reason why the subject is feeling better because of Pep19 supplementation. It has been shown that in obese subjects the improvement of QoL is linked with weight loss, which is directly linked to physical health improvement (weight loss, improvement in plasma biomarkers such as glucose and insulin levels and so on).

Another aspect of this study is the influence of Pep19 on sleep quality in obese subjects. There are a lot of studies suggesting an association between obesity and sleep disturbances. The most well study sleep disturbance associated to obesity is sleep apnea, but the increased visceral adipose tissue might be responsible for the secretion of inflammatory cytokines that could contribute to alter the sleep-wake rhythm, which impairs sleep quality. Animal data showed that Pep19 treatment of rats submitted a sugar supplementation (a model of insulin resistance) decrease visceral adipose tissue. Based on the animal data the investigators would like to study if Pep19 could change the sleep quality and if this change is correlated to the changes on body composition and metabolic parameters.

Pep19 has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods. Pep19 has no effect on the brain, heart, pancreas or skeletal muscle. It is highly purified, not allergenic or mutagenic, and free of microbes, metals and other contaminants.

Preliminary, open-label, uncontrolled studies have shown that Pep19 is well tolerated in rodents, beagles, and humans. Each of the beagles and humans received 5mg of Pep19 as an oral supplement in the form of a veggie capsule taken daily for 30 days. Each capsule was composed of the Pep19 plus microcrystalline excipient blended into a veggie capsule with composition as described below. No adverse events were observed. The only surprise was that a few of the humans spontaneously reported improved sleep quality.

This placebo controlled study will evaluate the effects of two doses of Pep19™ -- 2 mg and 5 mg - on two primary endpoints: quality of life and sleep quality. The lower 2 mg dose is being tested because analysis of the human data suggests that a lower normalized dose was associated with fat loss and improved sleep quality. It may be that 2mg has the same effect as 5mg and future use can rely on a 60% lower dose.

Objectives - The purpose of this study is to assess changes in quality of life and sleep quality.

Eligibility criteria: Inclusion Criteria:

1. Generally healthy adults between the ages of 40 and 60 years of age, i.e., adults who are community living and able to come to the clinic for qualification and followup appointments
2. BMI between 30 and 35 kg/m2

Exclusion Criteria:

1. Pregnancy, lactation
2. Anti-obesity supplements or medications, e.g. semaglutide

Primary outcomes:
measure: Improvement on QoL
timeFrame: 60 days
measure: Improvement on Sleep quality
timeFrame: 60 days
Secondary outcomes:
measure: Temperature
timeFrame: 60 days
measure: Blood pressure
timeFrame: 60 days
measure: Heart rate
timeFrame: 60 days
measure: circumference
timeFrame: 60 days
measure: blood tests
timeFrame: 60 days
measure: Body fat
timeFrame: 60 days
measure: Body weight
timeFrame: 60 days
Other outcomes:
Locations:
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC
state: Florida
Study officials:
affiliation: Precision Clinical Research
name: Jason Haffizulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reckziegel P, Festuccia WT, Britto LRG, Jang KLL, Romao CM, Heimann JC, Fogaca MV, Rodrigues NS, Silva NR, Guimaraes FS, Eichler RAS, Gupta A, Gomes I, Devi LA, Heimann AS, Ferro ES. A novel peptide that improves metabolic parameters without adverse central nervous system effects. Sci Rep. 2017 Nov 1;7(1):14781. doi: 10.1038/s41598-017-13690-9.
citation: Silverio R, Barth R, Heimann AS, Reckziegel P, Dos Santos GJ, Romero-Zerbo SY, Bermudez-Silva FJ, Rafacho A, Ferro ES. Pep19 Has a Positive Effect on Insulin Sensitivity and Ameliorates Both Hepatic and Adipose Tissue Phenotype of Diet-Induced Obese Mice. Int J Mol Sci. 2022 Apr 7;23(8):4082. doi: 10.3390/ijms23084082.