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临床试验/NCT06359327
NCT06359327已完成不适用

Effect of Consumption of Pep19 on Quality of Life

Proteimax Biotechnology Israel LTD2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Improvement on Sleep quality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Improvement on Sleep quality

时间窗: 60 days

Related to QoL, the study will use the questionnaires PSQI to assess quality of sleep.

Improvement on QoL

时间窗: 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.

次要结局

  • Body fat(60 days)
  • circumference(60 days)
  • Blood pressure(60 days)
  • Heart rate(60 days)
  • Temperature(60 days)
  • blood tests(60 days)
  • Body weight(60 days)

研究者

发起方
Proteimax Biotechnology Israel LTD
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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