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.
