People Science
Los Angeles, California, 90034, United States
NCT Number: NCT07245914
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Los Angeles, California, 90034, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any potential participants who:
Concomitant Conditions and Therapies:
All 125 study participants will be taking the study product, Pivit, throughout the course of the study. There is no placebo intervention for this study.
Time frame: 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.
Time frame: 12 weeks ; 3 months
Another outcome measure for this study will be to observe the impact of the study product, Pivit, on body mass index (using reported weight and height). This will be measured by assessing the change from baseline in body mass index after three months of study product use.
Time frame: 12 weeks; 3 months
A secondary outcome measure will be to assess the impact of the study product, Pivit, on gastrointestinal symptoms. This will be measured by assessing the change from baseline in Gastrointestinal Symptom Questionnaire score after 12 weeks of product use (Likert scale: Absent - I did not have this symptom at all Mild - I had this symptom occasionally, but it did not really bother me Moderate - I had this symptom often, it bothered me quite a bit Severe - I had this symptom very often, it bothered me a great deal), with a lower value indicating a better outcome.
Time frame: 12 weeks; 3 months
A secondary outcome measure will be to assess the impact of the study product, Pivit, on gastrointestinal symptoms. This will be measured by assessing the change from baseline in average scores on gastrointestinal symptoms including stomach discomfort, constipation, bloating, diarrhea, food noise, lightheadedness, and sweating after 12 weeks of product use using a 10-point VAS with 0 being absent and 10 being severe.
Time frame: 12 weeks; 3 months
The secondary outcome will be to assess the impact of Pivit on cognitive and behavioral components of eating. This will be assessed using the change from baseline using the Three Factor Eating Questionnaire (TFEQ) score after 12 weeks of product use. The TFEQ is a 4 point scale (Definitely true, Mostly true, Mostly false, Definitely false) with a lower score indicating a better outcome.
Time frame: 12 weeks; 3 months
A secondary outcome will be to assess the impact of the study product, Pivit, on individual appetite, hunger, cravings, night-time snacking and general well-being. This will be measured by a 5 point visual analog scale with 0 - strongly disagree to 5 - strongly agree, assessing the change from baseline in average weekly questionnaire scores for appetite, hunger and general after three months of product use.
Time frame: 12 weeks ; 3 months
The final secondary outcome will be to observe the safety and tolerability of the study product, Pivit. This will be measured by an assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and adverse event withdrawals reported over the study period of 12 weeks / 3 months.
Olfactive Biosolutions, Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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