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Recruiting NCT07442864

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

No phase Interventional Hunger Weight Change

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Leptin Balance Formula.
Who it may be relevant to
Registry conditions: Hunger, Weight Change. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Hunger Perception and Weight-Related Outcomes Following Use of a Leptin-Supporting Dietary Supplement Over 12 Weeks

Overview

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 supplement Leptin 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.

Primary outcome measures

  • Change in Hunger Perception [Time frame: Baseline and Week 12]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Efforia — New York

Identifiers

NCT: NCT07442864 · 43484

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗