Hunger, Weight Change
Conditions
Keywords
Hunger, Leptin, Weight Management
Brief 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/
Interventions
DIETARY_SUPPLEMENTLeptin Balance Formula
Participants will self-administer the Leptin Balance Formula daily for 12 weeks according to product labeling. The supplement is commercially available and includes African mango seed extract, chromium picolinate, Ceylon cinnamon, and alpha lipoic acid.
Sponsors
Efforia, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hunger Perception | Baseline and Week 12 | Change from baseline in self-reported hunger perception as measured by a standardized hunger perception questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline and Week 12 | Self-reported body weight change from baseline. |
| After-Meal Hunger and Fatigue Perception | Baseline, Week 4, Week 8, and Week 12 | Self-reported hunger and fatigue levels following meals using a structured questionnaire. |
Countries
United States
Contacts
CONTACTMatthew Amsden
Outcome results
None listed