- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442864
Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement
Evaluation of Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement Over 12 Weeks
Study Overview
Status
Conditions
Intervention / Treatment
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/
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew Amsden
- Phone Number: 646-679-2479
- Email: help@efforia.com
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- Efforia
-
Contact:
- Matthew Amsden
- Phone Number: (646) 679-2479
- Email: help@efforia.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Arm longitudinal where participants act as their own control
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hunger Perception
Time Frame: Baseline and Week 12
|
Change from baseline in self-reported hunger perception as measured by a standardized hunger perception questionnaire.
|
Baseline and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline and Week 12
|
Self-reported body weight change from baseline.
|
Baseline and Week 12
|
|
After-Meal Hunger and Fatigue Perception
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
Self-reported hunger and fatigue levels following meals using a structured questionnaire.
|
Baseline, Week 4, Week 8, and Week 12
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43484
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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