![]() LePort notes that once the devices were removed, participants could start eating normally again, which often leads to weight gain. Either they eroded the stomach or they passed into the intestines and they couldn’t get it out,” he said. Peter LePort, bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, California. “In the past multiple devices to put in your stomach to make you feel like there’s food in your stomach so you don’t want to eat more,” said Dr. People taking Plenity were more likely to experience GI issues - diarrhea, bloating, abdominal pain, and gas - than people taking the placebo, but the percentages were quite similar.įor example, 12.6 percent of people taking Plenity reported diarrhea compared to 8.5 percent of placebo users 11.7 percent of Plenity users reported bloating compared to 6.6 percent of placebo users. Participants using Plenity were twice as likely as placebo users to lose at least 10 percent.Īnd among participants with prediabetes or lifestyle-treated type 2 diabetes, people taking Plenity were six times more likely to lose 10 percent of their baseline weight by the end of the study. In the placebo group, 42 percent of participants lost 5 percent of baseline body weight, and 15 percent lost 10 percent or more. What’s more, nearly 60 percent of people who took the Plenity capsules lost 5 percent of their weight, and 27 percent achieved weight loss greater than 10 percent of baseline. While not a large difference, it’s statistically significant. This means neither the researchers nor the participants knew whether they were receiving Plenity or a placebo product until after the study was completed.Īt the end of the study term, participants who had been using the Gelesis weight loss aid lost 6.4 percent of their baseline weight versus 4.4 percent in the placebo group. The study was a double-blind, placebo-controlled study. The Gelesis Loss of Weight (GLOW) study, which was paid for by Gelesis, recruited 436 adults with a BMI between 27 and 40.įor 24 weeks (six months), participants were given either a placebo product or Plenity. The FDA greatly relied on the results of a 2018 study in the journal Obesity to give the thumbs up for Plenity. “The key to fiber supplements is to drink extra water, which by the way can help with weight loss,” she said. “Much like taking psyllium mixed with water to create a fiber-rich drink to keep you fuller longer, this new product appears to work the same way,” said Julie Upton, MS, RD, co-founder of Appetite for Health. The cells release the water they absorbed back into your gastrointestinal (GI) tract, then exit the body during a bowel movement.īecause the body doesn’t absorb the hydrogel - it passes through the gut and out the end of the GI tract - the FDA considers it to be a “device,” not a drug. The result is that you feel full and have less room for food, thus you’re likely to eat less.Īfter you eat, the hydrogel matrix moves out of the stomach, where it breaks down in the intestines. Each of the hydrogel cells can absorb up to 100 times its weight, growing in size to occupy space in the stomach and intestines. Once in the stomach, the capsules break apart, exposing the matrix to water. Inside each capsule the two ingredients form a three-dimensional hydrogel matrix. ![]() Plenity is taken as a three-capsule dose 20 to 30 minutes before you sit down for lunch or dinner. It may also be used with other weight loss medications. The FDA, in their sweeping approval of Plenity, cautions that it must be used alongside diet and exercise. People below that threshold weren’t approved to use previous weight loss drugs unless they had a preexisting medical condition, such as heart disease or sleep apnea. Most previously approved devices were for people only with a BMI above 30, or those in the obese category. This includes people in the overweight and obese BMI categories. In a first from the FDA, Plenity has been approved for use in people with a body mass index (BMI) of 25 to 40. Plenity, created by Boston biotech company Gelesis, is a hydrogel capsule made with a proprietary blend of cellulose (a type of fiber) and citric acid. The Food and Drug Administration (FDA) issued a rare approval for a new weight loss device this week. ![]() Share on Pinterest The FDA has approved a new weight loss aid that expands in your stomach to help you feel full with less food. ![]()
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