Fuzzle System for Appetite Control and Weight Management

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• DM Clinical Research — Bradenton

Идентификаторы

NCT: NCT07527559 · FUZ-CT-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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