Nutrition 21, Inc.
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…
Inclusion Criteria: * 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…
All 138 Participants will receive similar study product.
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