Quality of LifeNCT06359327
Effect of Consumption of Pep19 on Quality of Life
A study testing Pep19 2 mg and Pep19 5 mg in people with Quality of Life and Obesity, run by Proteimax Biotechnology Israel LTD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Obesity, Sleep Quality
- What is being tested?
- Pep19 2 mg and Pep19 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- BMI between 30 and 35 kg/m2
Who cannot join
- Pregnancy, lactation
- Anti-obesity supplements or medications, e.g. semaglutide
Trial locations and contacts
1 site in 1 country.
United States1 site
Precision Clinical Research, LLC
Sunrise, Florida, 33351
About this study
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.
Read the 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.
- Conditions
- Quality of Life, Obesity, Sleep Quality
- Being tested
- Placebo, Pep19 2 mg, Pep19 5 mg
- Keywords
- Peptide, Body weight managment, Sleep
- Medical subject headings
- Obesity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Subjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given placebo for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient.
Pep19 2 mgDietary supplement
Subjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given 2 mg of Pep19 for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient.
Pep19 5 mgDietary supplement
Subjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given 5 mg of Pep19 for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Pep19 2 mg | Active comparator | Not described Receives: Dietary Supplement: Pep19 2 mg |
| Pep19 5 mg | Active comparator | Not described Receives: Dietary Supplement: Pep19 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on QoL
The study main endpoint is QoL. The study involves standard assessments, in the study will use the questionnaires SF-12 to assess quality of life.
Measured: 60 days
Improvement on Sleep quality
Related to QoL, the study will use the questionnaires PSQI to assess quality of sleep.
Measured: 60 days
Secondary outcomes (7)
Temperature
The study involves standard assessments, in the study will use a thermometer to assess temperature in Celsius degrees.
Measured: 60 days
Blood pressure
In the study will be used a sphygmomanometer to measure blood pressure in mmHg.
Measured: 60 days
Heart rate
In the study will be used a heart rate measuring device to measure heart rate in beats per secound.
Measured: 60 days
circumference
In the study will be used a measuring tape to measure circumference in centimeters.
Measured: 60 days
blood tests
In the study will be used ELISA assay to measure triglycerides, , ALT, AST, C-reactive protein, glucose, insulin, HgBA1c. All results will be express in mmol/L.
Measured: 60 days
Body fat
In de study will be used DEXA scan to measure the porcentage of fat in each subject.
Measured: 60 days
Body weight
In the study we will use a scale to measure the participants' weight in kg.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start28 May 2024
- Primary completion28 Jul 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteimax Biotechnology Israel LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Haffizulla, MD, Principal investigator, Precision Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359327
- Sponsor's protocol ID
- Pro00075623
- Status last verified
- Nov 2024
- First submitted
- 27 Mar 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29093454Silverio 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.
PubMed 35456900
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Pep19 on Quality of Life
- ClinicalTrials.gov ID
- NCT06359327
- Acronym / sponsor ID
- Pro00075623
- Conditions
- Quality of Life, Obesity, Sleep Quality
- Keywords
- Peptide, Body weight managment, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Proteimax Biotechnology Israel LTDIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placebo |
| Pep19 2 mg | Active comparator | Dietary Supplement: Pep19 2 mg |
| Pep19 5 mg | Active comparator | Dietary Supplement: Pep19 5 mg |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
- BMI between 30 and 35 kg/m2
Key exclusion criteria (2 listed)
- Pregnancy, lactation
- Anti-obesity supplements or medications, e.g. semaglutide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given placebo for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient. | Dietary supplement | placebo |
| Pep19 2 mgSubjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given 2 mg of Pep19 for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient. | Dietary supplement | Pep19 2 mg |
| Pep19 5 mgSubjects will be given an informed consent as per the form submitted to Advarra IRB. 8 randomized subjects will be given 5 mg of Pep19 for 60 days. Placebo will be formulated as a dietary supplement in veggie capsules with microcrystalline cellulose excipient. | Dietary supplement | Pep19 5 mg |
Primary outcome
Improvement on QoL
Time frame: 60 days
The study main endpoint is QoL. The study involves standard assessments, in the study will use the questionnaires SF-12 to assess quality of life.
Improvement on Sleep quality
Time frame: 60 days
Related to QoL, the study will use the questionnaires PSQI to assess quality of sleep.
7 secondary outcomes
Temperature
Time frame: 60 days
Blood pressure
Time frame: 60 days
Heart rate
Time frame: 60 days
circumference
Time frame: 60 days
blood tests
Time frame: 60 days
Body fat
Time frame: 60 days
Body weight
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Background: PubMed 29093454Reckziegel 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.
- Background: PubMed 35456900Silverio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Haffizulla, MD principal investigator
Precision Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pep19 2 mg and Pep19 5 mg in people with Quality of Life and Obesity, run by Proteimax Biotechnology Israel LTD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on QoL (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06359327, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.