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NCT Number: NCT07442864

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

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.

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Key information

Conditions

Hunger Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Change

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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/

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Body Weight

    Time frame: Baseline and Week 12

    Self-reported body weight change from baseline.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Amsden

CONTACT

[email protected]

646-679-2479

Sponsors and collaborators

Lead sponsor

Efforia, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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