Fuzzle System for Appetite Control and Weight Management

Official title

A Randomized Controlled Study Evaluating the Safety and Effectiveness of the Fuzzle Intraoral Device for Weight Management

Overview

This study is evaluating whether the Fuzzle intraoral device can help adults with obesity lose weight when used alongside standard lifestyle counseling. Participants in this study will receive guidance on diet and behavior to support weight loss. Some participants will also receive the Fuzzle device, a custom-made removable oral appliance worn during the day. The study will compare weight loss outcomes between participants who use the Fuzzle device and those who follow lifestyle counseling alone over a 16-week period. Researchers will also explore whether use of the device increases the number of participants who achieve meaningful weight loss and may evaluate changes in selected metabolic markers in a subset of participants.

Detailed description

The purpose of this study is to evaluate the effectiveness of the Fuzzle intraoral device as an adjunct to standardized lifestyle counseling for weight management in adults with obesity (BMI ≥30 kg/m², ages 18-65).

This randomized, controlled study compares participants receiving the Fuzzle device in combination with standardized lifestyle counseling to those receiving lifestyle counseling alone over a 16-week period.

The primary objective is to assess whether use of the Fuzzle device results in greater percent total body weight loss at 16 weeks compared to standardized lifestyle counseling alone.

All participants receive standardized dietary and behavioral counseling, including caloric targets based on estimated energy expenditure and structured adherence support with regular follow-up. This design is intended to isolate the effect of the device as an adjunctive intervention to a controlled behavioral baseline.

The Fuzzle intraoral device is a custom-fabricated, removable oral appliance designed for daytime wear. It is intended to modulate oral sensory input within the stomatognathic system to influence eating-related behaviors, including reductions in snacking frequency and alterations in meal patterns. The device is non-invasive, reversible, and used in a home setting under provider supervision.

A subset of participants will provide blood samples for exploratory metabolic markers, including HbA1c, hsCRP, and ALT.

Interventions

• Device Fuzzle Intraoral Device
  The Fuzzle intraoral device is a custom-fabricated, removable oral appliance designed for daytime wear as an adjunct to weight management. The device is created from dental impressions to ensure a patient-specific fit. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene. The device is intended to modulate oral sensory input within the stomatognathic system, with the goal of influencing eating-related behaviors, including reductions in snacking fr
• Behavioral Lifestyle Management
  Participants receive standardized lifestyle management including dietary guidance, caloric targets based on estimated energy expenditure, and structured behavioral counseling. Participants track food intake using a mobile application with weekly check-ins to reinforce adherence.

Primary outcome measures

• Percent Total Body Weight Loss (%TBWL) at 16 Weeks [Time frame: From study enrollment to completion at 16 weeks]

Secondary outcome measures (7)

• Change in Body Mass Index (BMI) [Time frame: From study enrollment to completion at 16 weeks]
• Proportion of Participants Achieving ≥5% Total Body Weight Loss [Time frame: Baseline to Week 16]
• Change in Waist Circumference [Time frame: Baseline to Week 16]
• Change in Weight-Related Quality of Life (IWQOL-Lite-CT) [Time frame: Baseline to Week 16]
• Device Tolerability Assessed by Oral Comfort Visual Analog Scale (VAS), Adverse Event Incidence, and Device Adherence Metrics [Time frame: Baseline to Week 16]
• Exploratory Change in High-Sensitivity C-Reactive Protein (hsCRP) [Time frame: Baseline to Week 16]
• Exploratory Change in Alanine Aminotransferase (ALT) [Time frame: Baseline to Week 16]

Eligibility criteria

Inclusion criteria

• Adults aged 18-65 years
• Body mass index (BMI) ≥30 kg/m² at screening
• Willing and able to provide informed consent
• Willing to comply with study visits and procedures
• Willing to participate in standardized lifestyle counseling

Exclusion criteria

• Participation in another weight-loss clinical study within 90 days
• Pregnancy, breastfeeding, or intent to become pregnant during the study period
• History of eating disorders or uncontrolled psychiatric illness
• Oral or dental conditions preventing safe device use
• Current use of prescription or over-the-counter weight-loss medications
• A1C >8.0% at screening (glycemic subset exclusion only)
• Unstable diabetes medication regimen (glycemic subset exclusion only)
• Any medical condition that, in the investigator's judgment, would interfere with safe participation

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• DM Clinical Research — Bradenton

Identifiers

NCT: NCT07527559 · FUZ-CT-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗