Overweight (BMI > 25)NCT07909109
An Open Label Pilot Study Assessing the Impact of Chromium Picolinate Supplementation on Appetite and Cravings in Overweight Individuals
An observational study of Overweight (BMI > 25) and Appetite, run by Nutrition 21, Inc. at 1 site in United States.
Trial summary
This open-label, decentralized pilot study evaluates the effects of daily chromium picolinate supplementation (8 mg providing 1,000 mcg chromium) for 8 weeks on appetite, food cravings, and food-related intrusive thoughts ("food noise"). Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight (BMI > 25), Appetite, Craving
- What is being tested?
- Study Product
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to Jan 2027
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of healthy adults aged 35 to 70 years with a self-reported BMI between 25 and 31 kg/m² and moderate food cravings (FCQ-15 score of 25-54).
Who may be able to join
- Males/Females age 35-70 years old, inclusive
- Self-reported BMI between 25-31 kg/m²
- In good general health at the time of screening (Investigator discretion, applied against the objective screening data and the exclusion criteria below - i.e., confirmation that no significant, unlisted comorbidity or acute condition is present that would confound assessment of appetite/craving outcomes or compliance), defined as medically stable for at least the last 6 months.
- Self-reported weight stable, defined as body weight has not fluctuated significantly over the last 3 months. "Significantly" is defined as a change of more than 3% to 5% of total body weight, or a shift over 5 lbs (Pagidipati 2021) Moderate food cravings, defined as a score 25-54 on the Food Cravings Questionnaire -Reduced (FCQ-15)
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
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- Able to use a personal smartphone device and download the Chloe app by People Science.
- Able to receive shipment of the product and supplies at an address within the United States.
- Able to complete study assessments over the course of up to 15 weeks.
Who cannot join
- Participants actively engaged in weight loss programs or actively dieting.
- Participants taking any supplements (i.e. fat burners, etc.) specifically for weight loss/management (including appetite control)
- Participants taking any cinnamon, berberine, or chromium containing supplements.
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Current or prior use of a GLP-1 within the last 2 weeks
- Concomitant Therapies:
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- Participants receiving any investigational therapies or treatments within 30 days prior to consent.
- Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- Currently diagnosed with an Eating Disorder
- Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or 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 chromium containing products.
- 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. Contact the study team or a site near you to ask about taking part.
Lisa Capano-Wehrle contact
United States1 site, 1 recruiting
- Recruiting
People Science
Los Angeles, California, 90045
Noah Craft, MD, 213-342-5681, noah@peoplescience.health
About this study
This open-label, decentralized pilot study evaluates the effects of daily chromium picolinate supplementation (8 mg providing 1,000 mcg chromium) for 8 weeks on appetite, food cravings, and food-related intrusive thoughts ("food noise"). The study aims to enroll up to 110 evaluable healthy adults aged 35-70 years with a body mass index (BMI) between 25 and 31 kg/m². Participants are stratified into two cohorts: those without prior Glucagon-Like Peptide-1 (GLP-1) receptor agonist exposure (Cohort 1, n=80) and those with prior GLP-1 exposure following a 14-to-90-day washout period (Cohort 2, n=30).
Conducted entirely remotely via the Chloe mobile app, the study utilizes validated questionnaires (Food Cravings Questionnaire [FCQ-T], RAID-FN food noise inventory, appetite Visual Analogue Scales [VAS]), continuous glucose monitoring (CGM), daily meal logs, and weekly adverse event surveys to assess metabolic, behavioral, and subjective outcomes.
Read the detailed description
Chromium picolinate has demonstrated superior bioavailability and metabolic benefits, including healthy carbohydrate/glucose metabolism, insulin function, and lean muscle maintenance. Previous research suggests potential benefits in reducing carbohydrate cravings and food intake.
This decentralized pilot study extends these findings to a broader adult population of men and women using contemporary assessment tools and home-based technologies.
Primary Objective:
To evaluate the impact of daily chromium picolinate supplementation on hunger and cravings, measured by the change from baseline in the Food Cravings Questionnaire (FCQ-T) total score at the end of 8 weeks.
Secondary Objectives:
- Evaluate changes in food noise intensity using the Ro Allison Indiana Dhurandhar Food Noise (RAID-FN) inventory at Weeks 4 and 8.
- Assess changes in appetite profile (hunger, fullness, desire to eat, prospective consumption, snacking) via daily Visual Analogue Scale (VAS) scores.
- Measure changes in glycemic variability (mean glucose, standard deviation, % coefficient of variation, Mean Amplitude of Glycemic Excursions [MAGE], and Time in Range [TIR]) using Continuous Glucose Monitoring (CGM).
- Monitor safety and tolerability through the frequency, severity, and causality of adverse events (AEs) and serious adverse events (SAEs).
- Assess changes in self-reported body weight at Week 8.
- Gather participant feedback on the study experience and app-based tools.1
Study Design \& Participant Timeline
This is a prospective, open-label, single-arm, decentralized clinical trial lasting approximately 15 weeks per participant:
Screening Period (Up to 4 weeks): Remote electronic informed consent, collection of demographics and medical history, eligibility confirmation (including screening FCQ-15 score of 25-54), and confirmation of shipping address.
Enrollment \& Shipping Period (Up to 2 weeks): Randomization into the open-label arm, shipment of study product (1 capsule daily to be taken with breakfast or lunch) and supplies (Stelo CGM devices).
Baseline Period (1 week): Completion of baseline questionnaires (FCQ-T, RAID-FN) and application of the first CGM sensor.
Study Product Use Period (8 weeks / Days 8-63): Daily study product intake with daily app-based product confirmation, daily food/snack logging, daily appetite/hunger VAS completion, weekly adverse event surveys, and CGM wear during Weeks 1-2 and Weeks 7-8. Midpoint assessments (FCQ-T and RAID-FN) occur at Week 4.
End of Study (Up to 1 week post-product use): Final questionnaires (FCQ-T, RAID-FN, and experience survey).
- Conditions
- Overweight (BMI > 25), Appetite, Craving
- Being tested
- Study Product
- Keywords
- craving, appetite, control cravings
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study ProductDietary supplement
All 138 Participants will receive similar study product.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants who have not had previous GLP-1 exposure. Receives: Dietary Supplement: Study Product | |
| Cohort 2 | Participants with prior GLP-1 exposure. These subjects must undergo a washout period, with self-reported discontinuation of all GLP-1 therapy for a minimum of 14 days, and a maximum of 90 days, prior to study enrollment. Receives: Dietary Supplement: Study Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on hunger and cravings after taking Chromium Picolinate daily
The primary outcome for this study will be to evaluate the impact of daily chromium picolinate supplementation on hunger and cravings by using the change from baseline in the Food Cravings Questionnaire (FCQ-T) at the end of 4 and 8 weeks study product use. Baseline period will be compared as well.
Measured: 10 weeks
Secondary outcomes (6)
Impact on Food Noise after taking Chromium Picolinate daily
The secondary outcome for this study will be to evaluate the impact of daily chromium picolinate supplementation on food noise intensity. This will be done by using the change in Ro Allison Indiana Dhurandhar Food Noise (RAID-FN) Inventory score at the end of 4 and 8 weeks. Baseline period will be compared as well.
Measured: 10 weeks
Impact on Appetite Profile after taking Chromium Picolinate daily
The secondary outcome for this study will be to evaluate the impact of daily chromium picolinate supplementation on appetite profile. This will be done by using the change from baseline in appetite profile (hunger, fullness, desire to eat, prospective consumption, snacking) at the end of 8 weeks as measured by a Visual Analogue Scale (VAS) score. Baseline period will be compared as well.
Measured: 10 weeks
Impact on Fullness and mindful eating after taking Chromium Picolinate daily
The secondary outcome for this study will be to evaluate the impact of daily chromium picolinate supplementation on fullness and mindful eating.
This will be done by using the change from baseline at the end of 8 weeks as measured by the Hunger, Cravings, and Satiety scale. Baseline period will be compared as well.
Measured: 10 weeks
Impact on Glycemic Variability after taking Chromium Picolinate daily
The secondary outcome for this study will be to evaluate the impact of daily chromium picolinate supplementation on the glycemic variability.
This will be done by using the change from baseline in glycemic variability (glucose mean, SD, % CV, MAGE, TIR) at the end of Week 8 as measured by Continuous Glucose Monitoring (CGM).Change to intermediate time points will also be evaluated.
Measured: 10 weeks
Impact on safety and tolerability after taking Chromium Picolinate daily
The secondary outcome for this study will be to evaluate the safety and tolerability of the chromium picolinate supplementation.
This will be done by using the change of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product periods
Measured: 10 weeks
Impact on self-reported body weight after taking Chromium Picolinate daily
The secondary outcome for this study will be to evaluate the impact of daily chromium picolinate supplementation on self-reported body weight.
This will be done by using the change from baseline in self-reported body weight at the end of Week 8 as measured by at home weight scale (provisioned by the participant).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start31 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight (BMI > 25)Studies 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrition 21, 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
- NCT07909109
- Sponsor's protocol ID
- PS50
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be discussed internally
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study Assessing the Impact of Chromium Picolinate Supplementation on Appetite and Cravings in Overweight Individuals
- ClinicalTrials.gov ID
- NCT07909109
- Acronym / sponsor ID
- PS50
- Conditions
- Overweight (BMI > 25), Appetite, Craving
- Keywords
- craving, appetite, control cravings
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Nutrition 21, Inc.Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
This open-label, decentralized pilot study evaluates the effects of daily chromium picolinate supplementation (8 mg providing 1,000 mcg chromium) for 8 weeks on appetite, food cravings, and food-related intrusive thoughts ("food noise"). The study aims to enroll up to 110 evaluable healthy adults aged 35-70 years with a body mass index (BMI) between 25 and 31 kg/m². Participants are stratified into two cohorts: those without prior Glucagon-Like Peptide-1 (GLP-1) receptor agonist exposure (Cohort 1, n=80) and those with prior GLP-1 exposure following a 14-to-90-day washout period (Cohort 2, n=30).
Conducted entirely remotely via the Chloe mobile app, the study utilizes validated questionnaires (Food Cravings Questionnaire [FCQ-T], RAID-FN food noise inventory, appetite Visual Analogue Scales [VAS]), continuous glucose monitoring (CGM), daily meal logs, and weekly adverse event surveys to assess metabolic, behavioral, and subjective outcomes.
Detailed description
Chromium picolinate has demonstrated superior bioavailability and metabolic benefits, including healthy carbohydrate/glucose metabolism, insulin function, and lean muscle maintenance. Previous research suggests potential benefits in reducing carbohydrate cravings and food intake.
This decentralized pilot study extends these findings to a broader adult population of men and women using contemporary assessment tools and home-based technologies.
Primary Objective:
To evaluate the impact of daily chromium picolinate supplementation on hunger and cravings, measured by the change from baseline in the Food Cravings Questionnaire (FCQ-T) total score at the end of 8 weeks.
Secondary Objectives:
- Evaluate changes in food noise intensity using the Ro Allison Indiana Dhurandhar Food Noise (RAID-FN) inventory at Weeks 4 and 8.
- Assess changes in appetite profile (hunger, fullness, desire to eat, prospective consumption, snacking) via daily Visual Analogue Scale (VAS) scores.
- Measure changes in glycemic variability (mean glucose, standard deviation, % coefficient of variation, Mean Amplitude of Glycemic Excursions [MAGE], and Time in Range [TIR]) using Continuous Glucose Monitoring (CGM).
- Monitor safety and tolerability through the frequency, severity, and causality of adverse events (AEs) and serious adverse events (SAEs).
- Assess changes in self-reported body weight at Week 8.
- Gather participant feedback on the study experience and app-based tools.1
Study Design \& Participant Timeline
This is a prospective, open-label, single-arm, decentralized clinical trial lasting approximately 15 weeks per participant:
Screening Period (Up to 4 weeks): Remote electronic informed consent, collection of demographics and medical history, eligibility confirmation (including screening FCQ-15 score of 25-54), and confirmation of shipping address.
Enrollment \& Shipping Period (Up to 2 weeks): Randomization into the open-label arm, shipment of study product (1 capsule daily to be taken with breakfast or lunch) and supplies (Stelo CGM devices).
Baseline Period (1 week): Completion of baseline questionnaires (FCQ-T, RAID-FN) and application of the first CGM sensor.
Study Product Use Period (8 weeks / Days 8-63): Daily study product intake with daily app-based product confirmation, daily food/snack logging, daily appetite/hunger VAS completion, weekly adverse event surveys, and CGM wear during Weeks 1-2 and Weeks 7-8. Midpoint assessments (FCQ-T and RAID-FN) occur at Week 4.
End of Study (Up to 1 week post-product use): Final questionnaires (FCQ-T, RAID-FN, and experience survey).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Dietary Supplement: Study ProductParticipants who have not had previous GLP-1 exposure. |
| Cohort 2 | – | Dietary Supplement: Study ProductParticipants with prior GLP-1 exposure. These subjects must undergo a washout period, with self-reported discontinuation of all GLP-1 therapy for a minimum of 14 days, and a maximum of 90 days, prior to study enrollment. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of healthy adults aged 35 to 70 years with a self-reported BMI between 25 and 31 kg/m² and moderate food cravings (FCQ-15 score of 25-54).
Key inclusion criteria (9 listed)
- Males/Females age 35-70 years old, inclusive
- Self-reported BMI between 25-31 kg/m²
- In good general health at the time of screening (Investigator discretion, applied against the objective screening data and the exclusion criteria below - i.e., confirmation that no significant, unlisted comorbidity or acute condition is present that would confound assessment of appetite/craving outcomes or compliance), defined as medically stable for at least the last 6 months.
- Self-reported weight stable, defined as body weight has not fluctuated significantly over the last 3 months. "Significantly" is defined as a change of more than 3% to 5% of total body weight, or a shift over 5 lbs (Pagidipati 2021) Moderate food cravings, defined as a score 25-54 on the Food Cravings Questionnaire -Reduced (FCQ-15)
- Able to read and understand English.
Key exclusion criteria (15 listed)
- Participants actively engaged in weight loss programs or actively dieting.
- Participants taking any supplements (i.e. fat burners, etc.) specifically for weight loss/management (including appetite control)
- Participants taking any cinnamon, berberine, or chromium containing supplements.
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Current or prior use of a GLP-1 within the last 2 weeks
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 |
|---|---|---|
| Study ProductAll 138 Participants will receive similar study product. | Dietary supplement | Cohort 1, Cohort 2 |
Primary outcome
Impact on hunger and cravings after taking Chromium Picolinate daily
Time frame: 10 weeks
The primary outcome for this study will be to evaluate the impact of daily chromium picolinate supplementation on hunger and cravings by using the change from baseline in the Food Cravings Questionnaire (FCQ-T) at the end of 4 and 8 weeks study product use. Baseline period will be compared as well.
6 secondary outcomes
Impact on Food Noise after taking Chromium Picolinate daily
Time frame: 10 weeks
Impact on Appetite Profile after taking Chromium Picolinate daily
Time frame: 10 weeks
Impact on Fullness and mindful eating after taking Chromium Picolinate daily
Time frame: 10 weeks
Impact on Glycemic Variability after taking Chromium Picolinate daily
Time frame: 10 weeks
Impact on safety and tolerability after taking Chromium Picolinate daily
Time frame: 10 weeks
Impact on self-reported body weight after taking Chromium Picolinate daily
Time frame: 10 weeks
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 Nov 2026.
- Individual participant dataSharing planned: Undecided. This will 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.
Lisa Capano-Wehrle contact
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 Overweight (BMI > 25) and Appetite, run by Nutrition 21, 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 2 Nov 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?
Contact Megha Doshi, MD (5626736744 ext. 8566931265, megha@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on hunger and cravings after taking Chromium Picolinate daily (time frame: 10 weeks). 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 Nov 2026.