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NCT07442864NARecruitingAccepts Healthy Volunteers

Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement

Efforia, Inc

Start Date

9/10/2025

Completion Date

9/10/2026

Summary

This study evaluates changes in hunger perception and body composition-related measures following daily use of a commercially available dietary supplement formulated to support leptin-related metabolic signaling. Adult participants will self-administer the supplement for 12 weeks and complete periodic self-reported assessments related to appetite, hunger, and weight-related outcomes. Participants serve as their own control, with comparisons made between baseline and follow-up measurements. The study is designed to generate preliminary, real-world evidence regarding supplement use in a general wellness context.

Detailed Description

Leptin is a hormone involved in appetite regulation and satiety signaling. Dysregulation of leptin signaling has been associated with altered hunger perception and weight management challenges. While diet and physical activity are commonly emphasized in weight optimization strategies, hormonal contributors such as leptin are less frequently evaluated in real-world consumer settings. This single-arm, observational study is designed to explore changes in hunger perception and weight-related outcomes associated with daily use of the Leptin Balance Formula, a commercially available dietary supplement containing African mango seed extract, chromium picolinate, Ceylon cinnamon, and alpha lipoic acid. Participants will use the product for 12 weeks and complete electronic surveys and self-reported measurements at baseline and designated follow-up time points. The study is conducted under Efforia's Minimal Risk Umbrella Protocol and is intended as a signal-detection study to inform future, more controlled research designs. The study does not diagnose, treat, or prevent disease and is limited to general health and wellness outcomes. Study Design Study Type: Observational Observational Model: Single Group Assignment Time Perspective: Prospective Number of Arms: 1 Masking: None (Open Label) Primary Purpose: Other (Wellness / Signal Detection) More information can be found at the study recruitment landing page: https://app.efforia.com/leptin-balance-formula-weight-optimization/

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adults aged 18 years or older * Willing to pay for study supplies and able to take the dietary supplement daily for 12 weeks * Willing to complete electronic questionnaires and self-reported measurements * Able to provide informed consent Exclusion Criteria: * Pregnant or breastfeeding individuals * Known allergy or sensitivity to any supplement ingredients * Use of medications or supplements that could interfere with appetite or weight without medical clearance * Any medical condition that would make participation unsafe, as determined by the participant

Interventions

DIETARY_SUPPLEMENT

Leptin Balance Formula

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Conditions

HungerWeight Change

Locations

Efforia

New York, New York 10003

United States