Adults with overweight or obesity who used a removable, oral device while eating meals and snacks saw a mean excess weight loss of nearly 19% after 16 weeks, despite adherence to the device declining during the study period, according to a study.
“As evidenced in the literature, individuals who eat their meals quickly tend to consume larger meals, which can disassociate satiety from the amount of food consumed, which often leads to overeating and higher BMI,” Donna Ryan, MD, professor emerita and the interim executive director of the Pennington Biomedical Research Center in Baton Rouge, Louisiana, and colleagues wrote. “Conversely, slowing food consumption has been shown to reduce food intake, hasten satiety and support weight loss in individuals with overweight and obesity.”
The SmartByte system (Scientific Intake), described as a noninvasive, removable medical device placed only when eating, is designed to slow the eating rate by reducing the volume of the oral cavity and support mindful eating, according to the study background. In a previous randomized controlled trial of 173 patients with overweight or obesity, those assigned to use the device and watch a lifestyle intervention video saw a mean weight loss of 1.65% after 16 weeks vs. mean weight loss of 0.36% in those who viewed the video alone (P = .025). However, overall adherence was poor, and the FDA required a confirmatory study to further assess the effect of the device after 16 weeks in adults with overweight or obesity.
Ryan and colleagues analyzed data from 76 healthy adults aged 18 to 49 years with BMI between 27 kg/m² and 35 kg/m² who underwent physical exams and were fitted for the device, which includes an embedded, proprietary sensor to measure times, frequency and duration of device use at 5-minute intervals. Participants were instructed to wear the device during every meal and snack, as well as during the consumption of sugar-sweetened beverages, and remove and store the device when not in use. Participants also viewed an education video on healthy eating and were weighed and assessed every 2 weeks for 16 weeks. Coprimary endpoints were the proportion of participants achieving at least 5% weight loss at week 16 and mean total body weight loss at week 16 vs. baseline.
In the per-protocol population, mean total body weight loss at 16 weeks was 2.93%, with 30% of participants achieving at least 5% weight loss (range of weight loss, 5.1% to 9.1%). For those achieving at least 4% total body weight loss, mean weight loss was 6.3%.
In the intention-to-treat population, mean total body weight loss at week 16 was 2.05%, with 19.7% achieving at least 5% total body weight loss at week 16. For the 36 participants who were not in the per-protocol population, mean weight loss at 16 weeks was 1.45%, 16.6% achieved at least 4% weight loss and 8.3% achieved 5% weight loss.
In reviewing device sensor data, researchers found that 69% of the per-protocol population was compliant with device use. There were no serious adverse events reported; 12 participants reported 24 nonserious adverse events, including hard palate abrasion when food caught in the device and two tongue lacerations reported by one participant, both considered nonserious and mild.
“For patients who use the device at most meals, there may be clinically significant weight loss and, thus, health benefits,” the researchers wrote. “Importantly, as discussed, initial use of the device may help individuals learn to modify their eating habits, making continuing use less necessary.” – by Regina Schaffer
Disclosures: Scientific Intake funded this study, data analysis and development of the manuscript. Ryan reports she receives personal and other fees from Baro Nova, Eisai, Gila Therapeutics, Kwang Dong, Merck, Novo Nordisk, Orexigen, Real Appeal and Scientific Intake. Please see the study for the other authors’ relevant financial disclosures.