GLOBAL REGULATORY CLEARANCES ACHIEVED
FDA (US)
CE Mark (EU)
TGA (Australia)
Health Canada (CA)
Anvisa (Brazil)
Scientific Intake’s peer reviewed, published clinical research studies and FDA clearance assure SmartByte® is safe and effective.
Study 1 – Half of the subjects ate with SmartByte, half did not. Both groups ate until they were satisfied. Over the course of a full day, the SmartByte group indicated satiety on 533 fewer calories (23% less food) than the group without SmartByte. Additionally, the SmartByte users did not feel hunger sooner than the non-treated control group.1
Study 2 – Subjects were randomized into test and control groups. After 16 weeks, 48.8% of the device group lost > 5% of total body weight from baseline compared to 4.5% of the non-device control group. Device subjects showed a steady and downward trend of weight loss throughout the study which was continuing to decline upon study termination. Further evidence of the device’s effectiveness was the proportional trend between higher frequency of use and greater amounts of weight loss. 2
Study 3 – At 16 weeks completers average weight loss was -13.1 pounds (- 6.4 %). BMI dropped from an average of 31.5 to 29.5, waist circumference decreased by 2.4 inches. Fasting insulin went from 11.17 to 7.30. The 3 factor Eating Q indicated eating behavior change was significant. Cognitive restraint increased by 53%, disinhibited eating dropped by 61% and feelings of hunger decreased by 46%. Again, Device subjects showed a steady and downward trend of weight loss throughout the study which was continuing to decline upon study termination. Further evidence of the device’s effectiveness was the proportional trend between higher frequency of use and greater amounts of weight loss.3
Study 4 – Submitted to FDA resulting in de novo clearance. For the per-protocol population achieving > 4% or more weight loss, mean weight loss was 6.3% (range -4.3% – 9.1%).30% of the per-protocol population achieved > 5% TBL at week 16 (range of weight loss -5.1% – 9.1%). Subjects were given no dietary restrictions or physical activity requirements. As seen in other Scientific Intake studies, weight loss showed steady, downward trajectory over the course of the four-month study and was declining when the study ended. Once again, higher frequency of device use resulted in greater amounts of weight loss. 4
Published Research Linking Rapid Eating To Overeating. CLICK HERE
- Walden HM, Martin CK, Ortego LE, Ryan DH, Williamson DA.” A New Approach for Reducing Food Intake”. Obesity Research2004
- Roslin MS et al., “A Study of Dietary Restriction at the Oral Cavity “ presented at theObesity Society Annual Meeting2007
- McGee TL, Grima MT, Hewson ID, Jones KM, Duke EB, Dixon JB. “First Australian Experiences With an Oral Volume Restriction Device to Change Eating Behaviors and Assist with Weight Loss”. Obesity2012
- Ryan DH, Parkin GC, Longley WH, Dixon JB, Apovian C, Bode B. “Efficacy and Safety of an Oral Device to Reduce Food Intake and Promote Weight Loss.” Obesity Science and Practice2017