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Effect of Consumption of Pep19 on Quality of Life

NCT06359327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-06

No results posted yet for this study

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.

Conditions

  • Quality of Life
  • Obesity
  • Sleep Quality

Interventions

DIETARY_SUPPLEMENT

Placebo

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.

DIETARY_SUPPLEMENT

Pep19 2 mg

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.

DIETARY_SUPPLEMENT

Pep19 5 mg

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.

Sponsors & Collaborators

  • Proteimax Biotechnology Israel LTD

    lead INDUSTRY

Principal Investigators

  • Jason Haffizulla, MD · Precision Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2024-07-28
Completion
2024-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359327 on ClinicalTrials.gov