U.S. Residents

The Scientific Intake website is not intended for a U.S. audience. The website describes our product, Sensor Monitored Alimentary Restriction Therapy (SmartByte™). The product has not been cleared for marketing by the Food and Drug Administration and is not available for sale in the U.S.

SmartByte™ is limited by U.S. law to investigational use only. It has been designated Non Significant Risk by the FDA.

Outside the U.S., Scientific Intake's SmartByte™ is designated a Class I medical device and has been granted the CE Mark (Europe), and has been approved by Health Canada, Anvisa ( Brazil) and TGA (Australia).

I Understand

Frequently Asked Questions

  1. How does SmartByte™ work?
  2. How is SmartByte™ different from other weight loss solutions?
  3. What is satiety and how will it help me lose weight?
  4. How do I know if I am a candidate for SmartByte™ ?
  5. Do I need to eat a special diet when I use SmartByte™?
  6. How much weight can I expect to lose if I wear SmartByte™?
  7. What is sensor monitored weight loss?
  8. Is SmartByte™ comfortable?
  9. Can I talk when wearing SmartByte™?
  10. Is SmartByte™ an orthodontic retainer?
  11. Has the safety and efficacy of SmartByte™ been evaluated in clinical studies?
  12. What are the side effects of SmartByte™?
  13. Can I use SmartByte™ with other weight loss products?
  14. How will losing weight help me?

If you have other questions about SmartByte™ please contact us at info@scientificintake.com.

Answers

1. How does SmartByte™ work?

SmartByte™ is a safe, removable, custom made device that is placed comfortably in the upper palate (the roof of the mouth) only while eating. SmartByte™ decreases your oral capacity, so you take smaller bites, which slows food intake and allows onset of your body’s satiety response. Rapid eaters will no longer be able to gulp their food after only a few chews. Because using SmartByte™ requires more chewing of food, it permits more savoring and tasting of your meal or snack. Triggering your body’s satiety response and more oral processing of your food makes you feel satisfied on less.

Each SmartByte™ includes an embedded microsensor that enables you to monitor your usage and progress to your goal weight on a secure website. It is an automatic “journal,” so you don’t have to write anything down to keep track of your compliance. Your SmartByte™ sensor “journal”  shows personalized daily, weekly and monthly results. You can keep this information private or share it with a support group or your health care provider. You control access and can change who sees it at any time

2. How is SmartByte™ different from other weight loss solutions?

SmartByte™ is not a pill, a supplement, a program, a special diet or a device put into your body with surgery or an endoscope down your throat. It is a instantly removable, has no side effects and you decide when to use it. Sensor Monitored Alimentary Restriction Therapy ( SmartByte™) has been proven effective when used as directed in multiple clinical trials. At a time when overweight and obese populations are reaching new heights around the world, SmartByte™ offers a safe, easy to use tool that can be used alone or in combination with other solutions. Although individual results may vary, people who wear the device as directed achieve a healthy weight reduction of 3% to 8% of their body weight after 16 weeks.

3. What is satiety and how will it help me lose weight?

Satiety is your body’s build-in defense mechanism that guards against overeating. On average, it takes approximately 10 – 15 minutes for satiety to trigger – for your stomach to tell your brain that it has had enough. Because modern lifestyles are so rushed, we have become used to gulping our meals (and too many calories) in just a few bites and leaving us with a sense of hunger. Because SmartByte™ slows your rate of eating, it will allow you to feel satisfied from a meal after consuming less of it (and fewer calories). The two main reasons cited for failure to stick with a weight loss effort are: 1) I cant eat the foods I like. 2) I am hungry all the time. SmartByte™ has been proven effective without a punitive diet regimen. SmartByte™ users say that feel satisfied, but on less food because their brain gets the satiety message before overeating.

4. How do I know if I am a candidate for SmartByte™?

SmartByte™ has been studied on individuals with Body Mass Index (BMI) of 27 to 35 in good oral health. A good candidate for SmartByte™ is an individual who eats too quickly and is motivated to lose weight. If your oral health is in question, please see your dentist before using a SmartByte™. People who have dentures or removable dental work (e.g., removal bridge or “partials”) are not candidates for SmartByte™. If your teeth are ground down from bruxism or your oral anatomy won’t ensure a good fit for SmartByte™ device, this will be determined before your mold is taken or after your mold is received at Scientific Intake’s manufacturing facility. If you are not a candidate for SmartByte™,  you and your provider will be notified and no costs will occur.

5. Do I need to eat a special diet when I use SmartByte™?

SmartByte™ does not require a special diet or exercise. However, eating a variety of healthy, fresh food is better than a diet of highly processed, high calorie foods and physical activity always boosts weight loss efforts. SmartByte™ requires that you take responsibility for change and that you use the device during all eating episodes. The effectiveness of your SmartByte™ can be maximized by adopting a healthier lifestyle.

6. How much weight can I expect to lose if I wear SmartByte™?

In a study conducted at the Pennington Biomedical Research Center in the US, the daily food intake of people using SmartByte™ was reduced by 23% (533 fewer calories in a day) compared to the food intake of people not given the device. In a subsequent scientific study, 173 overweight and mildly obese people were evaluated in a randomized controlled clinical trial. Among those subjects who used SmartByte™ as directed, the average excess body weight loss (EWL) was 38.1%. This translated into an average of 1 – 2.5 pounds per week or up to 8% of their total body weight. A subsequent study conducted in Australia and published in OBESITY showed a mean total bodyweight loss of 6.36% (p-value < 0.001).

7. What is sensor monitored weight loss?

The microsensor in your SmartByte™ functions like your own automatic “journal” that monitors your device usage and tracks your progress to the goal weight you set. Periodically, you will place your device on a SmartByte™ Reader and upload your sensor data to a secure website where you can easily see your device usage, enter your current weight and see your progress to your target weight.

8. Is SmartByte™ comfortable?

The SmartByte™ Custom Palatal Impression Kit is used to create an mold of the upper palate (the roof) of the mouth so that your SmartByte™ can be custom-made to fit your mouth. The device is only placed when eating and a special compact carrying case is provided to protect your SmartByte™ when it is not in use. As noted above, if your oral health or oral anatomy is not adequate for a SmartByte™ you will not be eligible for SmartByte™. Many users tell us that their SmartByte™ experience is similar to contact lens. You notice it the first day or two but quickly get used to it.

9. Can I talk when wearing SmartByte™?

You will be able to speak when wearing SmartByte™. Some users may have a slight “lisp” when speaking with their device, especially in the beginning. However, you will find you become used to speaking with it very quickly. Since you control the placement of SmartByte™, you decide when to use it.

10. Is SmartByte™ an orthodontic retainer?

SmartByte™ is NOT an orthodontic retainer. While the device is custom made using some of the same safe materials as orthodontic devices, its patented and researched function, design and sensor are for weight loss only. It is made from scratch for each individual to decrease oral capacity causing smaller bites of food, increase chewing, preclude gulping and trigger satiety. It is only placed for about an hour a day when eating.  SmartByte™ does not move, retain the position of teeth or improve oral appearance  in any way.

SmartByte™ is designed to simulate a naturally occurring condition called Torus Palatinus, which is characterized by bony, lobulated outgrowths of the upper palate. People with this condition tend to be thin, because Torus Palatinus causes them to take small bites, eat slowly and allows them to feel satisfied on less food.

11. Has the safety and efficacy of SmartByte™ been evaluated in clinical studies?

Unlike many solutions vying for your attention, SmartByte™’s claims are from evidence-based, statistically reliable, clinical research.  The safety and efficacy of SmartByte™ has been proven in several clinical studies (See Science & Research) conducted at the highest scientific standards.  Both our Pennington and pivotal trials have been reviewed and accepted at the TOS (The Obesity Society) Annual Meeting, which sets SmartByte™ apart from questionable weight loss products.

12. What are the side effects of SmartByte™?

SmartByte™ is a proven weight loss solution without side effects. The device functions without pharmaceuticals, chemicals, herbs, injections, special diets, stomach surgery or balloons temporarily placed in the stomach. It is a removable, biocompatible tool designated as a Class I (safest) medical device in Europe, Canada, Brazil and Australia. The SmartByte™ is currently under review at the U.S. Food and Drug Administration. It has been designated Non- Significant Risk  by FDA and is currently for investigational use only. It is removable, has no moving parts and is used approximately 45 to 60 minutes per day (only when consuming food).

13. Can I use SmartByte™ with other weight loss products?

Because SmartByte™ has no side effects and does not work by chemically affecting the brain, heart or digestive system, it can be used in combination with other weight loss aids without increasing the risks posed by pharmacotherapy. Since it works at the gateway to the body not the stomach, it may be used in conjunction with surgical procedures in the gut as well as before, during or  after other stomach based interventions such as temporarily placed balloons. Academic obesity experts agree that combination therapies produce greater weight loss faster. Adding a healthy diet and exercise to any weight loss solution is a safe and effective form of combination therapy.

14. How will losing weight help me?

Maintaining a healthy weight is important because obesity can cause many serious health problems, including heart disease, stroke, diabetes, respiratory problems, sleep apnea, osteoarthritis, low self esteem, GERD and some cancers. The National Institutes of Health Guidelines and most scientists who specialize in overweight and obesity agree that even a small amount of weight loss – even 3% – 4% of body weight can have a positive health effect on people with a BMI over 25.

 

© 2017 Scientific Intake Limited Co.