Obesity &Amp;Amp;Amp; OverweightNCT07245914
A Consumer Health Study Evaluating the Impact of Pivit on Weight Loss and Appetite in Overweight Individuals
An observational study of Obesity &Amp;Amp;Amp; Overweight and Obesity (Body Mass Index &Amp;Amp;Amp;Amp;gt;30 kg/m2), run by Olfactive Biosolutions, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity &Amp;Amp;Amp; Overweight, Obesity (Body Mass Index &Amp;Amp;Amp;Amp;gt;30 kg/m2)
- What is being tested?
- The Study Product (Pivit)
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 26 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- The Study Product (Pivit)
- Keywords
- obesity, overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: The Study Product (Pivit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks; 3 months
Secondary outcomes (6)
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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks ; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start30 Jul 2025
- Primary completion26 Jan 2026 (estimated)
- Study completion26 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp;Amp;Amp; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olfactive Biosolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, MD, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245914
- Sponsor's protocol ID
- PS16
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will need to be discussed internally.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Consumer Health Study Evaluating the Impact of Pivit on Weight Loss and Appetite in Overweight Individuals
- ClinicalTrials.gov ID
- NCT07245914
- Acronym / sponsor ID
- PS16
- Keywords
- obesity, overweight
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Olfactive Biosolutions, Inc.Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 26 Jan 2026 (estimated)
- Study completion
- 26 Feb 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Product Group | – | Dietary Supplement: The Study Product (Pivit)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Study Product Group |
Primary outcome
Weight
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.
6 secondary outcomes
BMI
Time frame: 12 weeks ; 3 months
Gastrointestinal Symptoms
Time frame: 12 weeks; 3 months
Gastrointestinal Symptoms
Time frame: 12 weeks; 3 months
Cognition and Behavior
Time frame: 12 weeks; 3 months
General Health and Well-Being
Time frame: 12 weeks; 3 months
Adverse Events
Time frame: 12 weeks ; 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided. This will need to be discussed internally.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft, MD principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity &Amp;Amp;Amp; Overweight and Obesity (Body Mass Index &Amp;Amp;Amp;Amp;gt;30 kg/m2), run by Olfactive Biosolutions, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 12 weeks; 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.