NCT07442864

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 10, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

March 2, 2026

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

HungerLeptinWeight Management

Outcome Measures

Primary Outcomes (1)

  • Change in Hunger Perception

    Change from baseline in self-reported hunger perception as measured by a standardized hunger perception questionnaire.

    Baseline and Week 12

Secondary Outcomes (2)

  • Change in Body Weight

    Baseline and Week 12

  • After-Meal Hunger and Fatigue Perception

    Baseline, Week 4, Week 8, and Week 12

Study Arms (1)

Single Arm longitudinal where participants act as their own control

EXPERIMENTAL

Single Arm longitudinal where participants act as their own control

Dietary Supplement: Leptin Balance Formula

Interventions

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.

Single Arm longitudinal where participants act as their own control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Matthew Amsden

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

September 10, 2025

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

March 2, 2026

Record last verified: 2025-09

Locations