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| Name | Class |
|---|---|
| People Science, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Product Group | All 125 study participants will be receiving the study product, Pivit, throughout the course of the study. There is no placebo group for this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Study Product (Pivit) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 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. | 12 weeks; 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | 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. | 12 weeks ; 3 months |
| Gastrointestinal Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
Any potential participants who:
Concomitant Conditions and Therapies:
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Study participants must be 18 years or older, have a body mass index between 25 and 34.9, glucagon-like peptide-1 (GLP1) naive, and interested in trying Pivit, the study product, for themselves.
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| Name | Affiliation | Role |
|---|---|---|
| Noah Craft, MD | People Science, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People Science | Los Angeles | California | 90034 | United States |
This will need to be discussed internally.
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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. |
| 12 weeks; 3 months |
| Gastrointestinal Symptoms | 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. | 12 weeks; 3 months |
| Cognition and Behavior | 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. | 12 weeks; 3 months |
| General Health and Well-Being | 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. | 12 weeks; 3 months |
| Adverse Events | 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. | 12 weeks ; 3 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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