A Consumer Health Study Evaluating the Impact of Pivit on Weight Loss and Appetite in Overweight Individuals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study is to observe the impact of Pivit on body weight in overweight individuals. Additionally, the study aims to observe the impact of the product on appetite, hunger, cravings, and general well-being via activities and technologies that can successfully and effectively be completed in a home setting. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the impact of this product in this population.
The study team will examine the outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home body weight measurement using a personal scale. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and at-home body weight measurement. Findings from this study will contribute knowledge toward the tolerability and formulation of the plant-derived consumer product and the design of future studies.
详细描述
Pivit is a proprietary and patented formulation of food molecules, designed to act on receptors in the gut to cause a natural secretion of GLP-1 and GIP hormones. GLP-1 and GIP are hormones that naturally delay stomach emptying to reduce appetite and trigger the pancreas to secrete insulin which regulates blood sugar. Pivit has been shown to naturally increase GLP-1 and GIP in human cellular studies and in initial consumer trials, which in turn increase feelings of satiety and lessen hunger pangs, lower blood sugar and support healthy insulin sensitivity. Pivit may also lessen interest in alcohol and reduce 'food noise,' thoughts about food throughout the day and curtail the urge to snack.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and older
- •Has self-reported body mass index (BMI) between 25 and 34.9 kg/m
- •Interested in learning about weight management and appetite and in trying Pivit product for themselves.
- •GLP-1 medication naive or has not taken any GLP-1 inducing weight-loss medications prior to enrollment.
- •Willingness to refrain from taking any weight loss supplements during the study.
- •Has a personal digital weight scale at home to use during the study.
- •In good general health at the time of screening (Investigator discretion).
- •Able to read and understand English.
- •Able to read, understand, and provide informed consent.
- •Able to use a personal smartphone device and download Chloe by People Science.
- •Able to receive shipment of the product at an address within the United States.
- •Able to complete study assessments over the course of up to 17 weeks.
排除标准
- •Any potential participants who:
- •Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- •Currently on or planning to start a fad diet, keto diet, pure carnivore diet, raw food diet, fruitarian diet, liquid diet (does not include vegans or vegetarians)
- •Concomitant Conditions and Therapies:
- •Any investigational therapies or treatments within 30 days prior to enrollment.
- •GLP-1 receptor agonists and related incretin mimetics, (e.g. semaglutide (Ozempic, Rybelsus), dulaglutide (Trulicity), exenatide (Byetta, Bydureon), liraglutide (Victoza, Saxenda), lixisenatide (Adlyxin), sitagliptin (Januvia, Janumet), saxagliptin (Onglyza, Komblglyze), alogliptin (Nesina, Kazano, Oseni), linagliptin (Tradjenta, Jentadueto) or tirzepatide (Mounjaro)
- •Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- •Currently pregnant, planning to become pregnant in the next 1 month, or breastfeeding
- •Any underlying medical conditions or comorbidities that may confound the evaluation of the study outcomes.
- •Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- •Known hypersensitivity or previous allergic reaction to Cinnamaldehyde, Spearmint Oil, Eugenol, Butyl butyryl lactate, Benzyl acetate, Lauric acid, Sodium-Copper Chlorophyllin, Sunflower Seed Oil, Gelatin, Glycerin
- •Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
结局指标
主要结局
Weight
时间窗: 12 weeks; 3 months
The primary outcome measure for this study will be to observe the impact of the study product, Pivit, on individual weight. This will be measured by assessing the change from baseline in body weight after three months of study product use.
次要结局
- BMI(12 weeks ; 3 months)
- Gastrointestinal Symptoms(12 weeks; 3 months)
- Cognition and Behavior(12 weeks; 3 months)
- General Health and Well-Being(12 weeks; 3 months)
- Adverse Events(12 weeks ; 3 months)