Plenity Now Is FDA-Approved For Weight Management


Posted on: April 29, 2019

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e Plenity to think about when it comes to weight-management What is Plenity now? It is a device that the U S. Food and Drug Administration (FDA) has just approved to help with weight management, according to Gelesis Gelesis is the Boston-based company that developed Plenity, which used to be called Gelesis 100, not to be confused with Terminator Genisys Gelesis will soon market the device on a prescription basis for adults who have a Body Mass Index (BMI) of 25 to 40 kg/m 2 As a reminder, here's what different BMI levels mean, according to a Centers for Disease Control and Prevention (CDC) website : If your BMI is less than 18. 5, it falls within the underweight range. If your BMI is 185 to <25, it falls within the normal If your BMI is 250 to <30, it falls within the overweight range If your BMI is 30. 0 or higher, it falls within the obese range How is Plenity supposed to help with weight management? Let's expand on Plenity, which is basically what this treatment does Plenity comes in a capsule that you can swallow with water about a half-an-hour before a meal It consists of cellulose (the stuff found in plants) and citric acid that form a three-dimensional hydrogel matrix Once released in your stomach, this matrix can then absorb water and then expand in size, up to about 100 times, occupying space in your stomach and intestines Thus, Plenity plus water makes you literally full of it. In this case, being full of it can be good, leaving less room for food and keeping you from eating as much But rather than getting absorbed by your intestines, this matrix should eventually just pass through your gut and out with your poop. Here is a video from the company on how it works: FDA approval came after Plenity demonstrated promising results in the Gelesis Loss Of Weight (GLOW) study published in the journal Obesity last year This was a placebo-controlled (some got Plenity, some got placebo), double-blinded (meaning that neither the subject nor the person giving the treatment or placebo knew who was getting what) clinical trial In it, 436 adults who had BMIs between 27 and 40 kg/m2, received either Plenity or a placebo for 24 weeks Those who had received Plenity throughout the study period ended up losing on average a greater percentage of their body weight (64%) compared to those who had just gotten placebo (44%) Those who had received Plenity were also twice as likely to lose at least 5% and at least 10% of their body weight than those who had taken placebo Among patients with either prediabetes or type 2 diabetes (that wasn't currently being treated with medications), those who had taken Plenity were six times more likely to have lost 10% or more of their body weight than those who taken placebo The study did not raise any major safety concerns about Plenity In the study, those who had taken Plenity were also more likely to suffer gastrointestinal issues such as diarrhea (126% of those who had taken Plenity versus 85% of those who had received placebo), abdominal distension (117% versus 66%), infrequent bowel movements (94% versus 47%), constipation (54% versus 5 2%), abdominal pain (5. 4% versus 28%), and flatulence (85% versus 52%) Presumably the last was more farting than usual, because you can't tell me that only about 52% to 5 4% of all participants had farted at some point during the study. So should you try Plenity for weight management? The GLOW study had its limitations For example, it only followed participants for 24 weeks, which is about six months As seen on numerous occasions,including after The Biggest Loser show, as I covered previously for Forbes , short term weight loss does not necessarily mean long-term weight loss So the question remains if your body would eventually adapt to such a treatment, resulting in weight regain Moreover, taking Plenity wasn't the only things that the participants did during the study Both the Plenity and the placebo groups remained on low calorie diets (300 kcal/day below their calculated energy requirements) and engaged in moderate‐intensity exercise each day Therefore, Plenity is not meant to be a replacement for proper diet and exercise Plenity should not replace maintaining a healthy diet (Photo: Getty Images) Getty While it is good to have another option for weight management, Plentity certainly should not be the first thing that you try to manage your weight It probably shouldn't be the second or third thing either Instead, lifestyle modifications should always come first Since Plenity has been approved for a wide range of BMIs, the concern is that some may try to use this as a method to get away with eating unhealthy diets (eg, the All Margerine and High Fructose Corn Syrup diet) or not exercising For now, be cautious with Plentity. Only take it when other more traditional options have not worked and you are under the care of a doctor who really understands weight management Plenity is definitely not for everyone, especially if your esophagus, stomach or intestines have existing issues like strictures or previous surgery Also, don't take Plenity when you are pregnant, as its safety during pregnancy has yet to be determined Again, weight is a complex systems problem If you are looking for that magic pill, that magic potion, or that magic diet, you ain't going to find one Weight management can be very challenging, requiring you and those caring for you to use a system of approaches Plenity could potentially fit in that system in certain cases But it's not like you will be able to just say, "Plenity now," in your best Frank Costanza-voice and everything will be magically fine

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