Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-03-27
Brief Title:
Effect of Consumption of Pep19 on Quality of Life
Sponsor:
Proteimax Biotechnology Israel LTD
Organization:
Proteimax Biotechnology Israel LTD
Study Overview
Official Title:
Effect of Consumption of Pep19 on Quality of Life
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 38 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 ones 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 38 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
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 ones 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 38 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None