An observational study in Overweight (BMI > 25), Appetite and Craving, sponsored by Nutrition 21, Inc.. Recruiting at 1 site in United States. Open to participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Nutrition 21, Inc. · Observational
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.
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:
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).
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 138 is below the median of 154 across 424 observational studies indexed under Overweight.
Browse Overweight studies →Nutrition 21, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receiving any therapies or treatments within 30 days prior to consent.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who have not had previous GLP-1 exposure.
Dietary Supplement: Study Product
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.
Dietary Supplement: Study Product
All 138 Participants will receive similar study product.
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.
Time frame: 10 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 10 weeks
Plan to share: Undecided — This will be discussed internally
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nutrition 21, Inc.