Obesity & Overweight
Conditions
Keywords
Obesity, Overweight, Weight, Weight Management, Fuzzle, Fuzzle Device
Brief summary
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
DEVICEFuzzle 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 frequency and alterations in meal patterns. It is non-invasive, reversible, and used in a home setting under provider supervision.
BEHAVIORALLifestyle 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.
Sponsors
Fuzzle Operating Co.
Dynamed Clinical Research
Advarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Total Body Weight Loss (%TBWL) at 16 Weeks | From study enrollment to completion at 16 weeks | Percent total body weight loss (%TBWL) will be compared between study arms at Week 16. %TBWL is calculated as \[(baseline body weight - Week 16 body weight) ÷ baseline body weight\] × 100, where higher values indicate greater weight loss. Body weight will be measured using standardized procedures during in-person clinic visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | From study enrollment to completion at 16 weeks | Body mass index (BMI, kg/m²) will be calculated as weight in kilograms divided by height in meters squared and compared between study arms based on change from baseline to Week 16. |
| Proportion of Participants Achieving ≥5% Total Body Weight Loss | Baseline to Week 16 | The proportion of participants achieving at least 5% reduction from baseline body weight at Week 16 will be compared between study arms. |
| Change in Waist Circumference | Baseline to Week 16 | Waist circumference (cm) will be measured using standardized methods at clinic visits and compared between study arms based on change from baseline to Week 16. |
| Change in Weight-Related Quality of Life (IWQOL-Lite-CT) | Baseline to Week 16 | Weight-related quality of life will be assessed using the IWQOL-Lite-CT instrument, with scores compared between study arms based on change from baseline to Week 16. Higher scores indicate improved quality of life. |
| Device Tolerability Assessed by Oral Comfort Visual Analog Scale (VAS), Adverse Event Incidence, and Device Adherence Metrics | Baseline to Week 16 | Fuzzle system tolerability will be evaluated using participant-reported comfort, safety monitoring, and adherence to use. Oral comfort will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no discomfort and 10 indicates extreme discomfort, collected at regular intervals throughout the study period. Adverse events will be recorded and categorized by frequency, severity (mild, moderate, severe), and relationship to the Fuzzle system. Device adherence will be measured using system-recorded and/or participant-reported usage, including average daily wear time and percentage of prescribed use over the study period. |
| Exploratory Change in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline to Week 16 | In a predefined subset of participants with baseline HbA1c between 5.7% and 7.5%, change from baseline to Week 16 in high-sensitivity C-reactive protein (hsCRP), measured in milligrams per liter (mg/L), will be evaluated. Analyses will be descriptive. |
| Exploratory Change in Alanine Aminotransferase (ALT) | Baseline to Week 16 | In a predefined subset of participants with baseline HbA1c between 5.7% and 7.5%, change from baseline to Week 16 in alanine aminotransferase (ALT), measured in units per liter (U/L), will be evaluated. Analyses will be descriptive. |
Countries
United States
Contacts
CONTACTJeremy McConnell, MD
CONTACTBrandon Essink, MD
PRINCIPAL_INVESTIGATORJeremy McConnell, MD
Dynamed Clinical Research
Outcome results
None listed