Clinical Results

Scientific Intake’s peer reviewed, published clinical research studies and FDA clearance assure users that SmartByte is safe and effective. In addition to use by hundreds of consumers in the U.S. and Canada, SmartByte data has been collected on 379 adults measured over 178,000 eating episodes.

For a clinical trial or research study to be valid, the methodology must be designed by scientists experienced in the field of study and approved by an independent Institutional Review Board (IRB). If the results are statistically reliable and evidence based they scrutinized by another group of experts (Peer Review). Only after completion of these extensive efforts can the study be accepted and published in a medical journal.

In addition to use by hundreds of consumers in the U.S. and Canada, Scientific Intake has conducted four clinical trials. 379 adults used SmartByte for over 178,000 eating episodes.

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 (SmartByte) and control (no SmartByte) groups. After 16 weeks, half of the subjects who used SmartByte as directed achieved 38.1% Excess Weight Loss (EWL). Total body weight loss (TBL) ranged from 5% to 10.1%. Average TBL was 6.4%.2

Study 3 - 20 adults received SmartByte, 16 subjects completed the four month study. Average weight loss was 13.2 lbs, BMI dropped from an average of 31.5 to 29.5, waist circumference decreased by 2.4 inches. Eating behavior change was significant: cognitive restraint increased by 53%, disinhibited eating dropped by 61% and feelings of hunger dropped by 46%.3

Study 4 - 79 subjects received SmartByte. At 16 weeks, 40% of the subjects who used it as directed lost an average of 6.3% of their total body weight. The range of total body weight loss was 4.3% to 9.1%.4

1. Walden HM, Martin CK, Ortego LE, Ryan DH, Williamson DA.” A New Approach for Reducing Food Intake”. Obesity Research 2004

2. Roslin MS et al., “A Study of Dietary Restriction at the Oral Cavity “ presented at the Obesity Society Annual Meeting 2007

3. 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”. Obesity 2012

4. 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 Practice 2017

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