HungerNCT07442864
Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement
A study testing Leptin Balance Formula in people with Hunger and Weight Change, run by Efforia, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hunger, Weight Change
- What is being tested?
- Leptin Balance Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Efforia
New York, New York, 10003
Matthew Amsden, (646) 679-2479, help@efforia.com
About this study
Official title: Evaluation of Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement Over 12 Weeks
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.
Read the 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/
- Conditions
- Hunger, Weight Change
- Being tested
- Leptin Balance Formula
- Keywords
- Hunger, Leptin, Weight Management
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leptin Balance FormulaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm longitudinal where participants act as their own control | Experimental | Single Arm longitudinal where participants act as their own control Receives: Dietary Supplement: Leptin Balance Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hunger Perception
Change from baseline in self-reported hunger perception as measured by a standardized hunger perception questionnaire.
Measured: Baseline and Week 12
Secondary outcomes (2)
Change in Body Weight
Self-reported body weight change from baseline.
Measured: Baseline and Week 12
After-Meal Hunger and Fatigue Perception
Self-reported hunger and fatigue levels following meals using a structured questionnaire.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start10 Sep 2025
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HungerStudies of the same condition, open and under way.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442864
- Sponsor's protocol ID
- 43484
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement Over 12 Weeks
- ClinicalTrials.gov ID
- NCT07442864
- Acronym / sponsor ID
- 43484
- Conditions
- Hunger, Weight Change
- Keywords
- Hunger, Leptin, Weight Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm longitudinal where participants act as their own control | Experimental | Dietary Supplement: Leptin Balance FormulaSingle Arm longitudinal where participants act as their own control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leptin Balance FormulaParticipants 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. | Dietary supplement | Single Arm longitudinal where participants act as their own control |
Primary outcome
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.
2 secondary outcomes
Change in Body Weight
Time frame: Baseline and Week 12
After-Meal Hunger and Fatigue Perception
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Study recruitment landing pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leptin Balance Formula in people with Hunger and Weight Change, run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden (646-679-2479, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hunger Perception (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.