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ACTIVE NOT RECRUITING

NCT07245914

A Consumer Health Study Evaluating the Impact of Pivit on Weight Loss and Appetite in Overweight Individuals

Sponsor: Olfactive Biosolutions, Inc.

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

125

Start Date

2025-07-30

Completion Date

2026-02-26

Last Updated

2026-01-02

Healthy Volunteers

Yes

Conditions

Obesity &Amp;Amp;Amp; Overweight Obesity (Body Mass Index &Amp;Amp;Amp;Amp;gt;30 kg/m2)

Interventions

DIETARY_SUPPLEMENT

The Study Product (Pivit)

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.

Inclusion Criteria: * Age 18 years and older * Has self-reported body mass index (BMI) between 25 and 34.9 kg/m2. * 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. Exclusion Criteria: 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.

Locations (1)

People Science

Los Angeles, California, United States