Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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/
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm longitudinal where participants act as their own control | Experimental | Single Arm longitudinal where participants act as their own control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leptin Balance Formula | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hunger Perception | Change from baseline in self-reported hunger perception as measured by a standardized hunger perception questionnaire. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Self-reported body weight change from baseline. | Baseline and Week 12 |
| After-Meal Hunger and Fatigue Perception | Self-reported hunger and fatigue levels following meals using a structured questionnaire. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Amsden | Contact | 646-679-2479 | help@efforia.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Efforia | Recruiting | New York | New York | 10003 | United States |
Not provided
| Label | URL |
|---|---|
| Study recruitment landing page | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, Week 4, Week 8, and Week 12 |