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

NCT07245914 | Active Not Recruiting

• 1 other identifier: PS16
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

obesity; overweight

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• BMI

  12 weeks ; 3 months

• Gastrointestinal Symptoms

  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

Study Arms (1)

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.

Dietary Supplement: The Study Product (Pivit)

Interventions

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.

Study Product Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Olfactive Biosolutions, Inc.: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science

Los Angeles, California, 90034, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Noah Craft, MD

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: November 24, 2025
• Study Start: July 30, 2025
• Primary Completion: January 26, 2026
• Study Completion: February 26, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-11

Locations

US (1)