For 24 months (six months), participants were given either a placebo merchandise or Plenity.
“Similar to taking psyllium blended with water to make a fiber-rich drink to keep you fuller longer, this new product appears to work the identical way,” explained Julie Upton, MS, RD, co-founder of Appetite for Health.
“Generally speaking, I believe these all some type of gimmick that the patient uses to take in less calories, as in the long run, it comes down to calories. You are going to gain weight if you take in too many. Should you take in too little, you’re going to lose weight,” LePort said.
The preliminary studies on Plenity do reveal promising results, but long-term consequences are always the secret to any and all weight loss products or plans. This includes individuals in the overweight and BMI categories.
“In the past [there are ] multiple devices to set in your stomach to make you feel as if there is food in your stomach so you don’t want to consume more,” explained Dr. Peter LePort, bariatric physician and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, California.
The FDA heavily depended on the results of a 2018 study in the journal Obesity to give the thumbs up for Plenity.
In the close of the study period, participants who had been using the Gelesis weight loss aid dropped 6.4 percent of the baseline weight versus 4.4 percent in the placebo group. While not a large difference, it’s statistically significant.
“They’ve always had some issue. Either they eroded the gut or they passed in the intestines and also they could not get it out,” he explained.
Because the body doesn’t absorb the hydrogel — it moves through the intestine and outside the end of the GI tract — the FDA considers it to be a”device,” not a medication.
How can Plenity work?
LePort points out that Plenity, although not having an established price point nevertheless, is very likely to be many times less expensive than surgery.
People below that threshold weren’t approved to use preceding weight loss drugs unless they had a preexisting health illness, such as heart disease or sleep apnea.
Plenity is chosen as a three-capsule dose 20 to 30 minutes before you sit down for dinner or lunch.
“If this device reduces the number of calories you’re able to take within an 24-hour interval, then you’ll lose weight up to the point where you are taking in the right number of calories,” he added.
The outcome is that you feel complete and have less space for food, so you’re very likely to consume less.
Individuals taking Plenity were more likely to encounter GI problems — diarrhea, bloating, abdominal pain, and gas — more than people taking the placebo, but the percentages were rather similar.
For example, 12.6 percent of people taking Plenity reported nausea compared to 8.5 percent of placebo users; 11.7 percent of Plenity users reported bloating compared to 6.6 percent of placebo users.
The Food and Drug Administration (FDA) issued a rare acceptance for a brand new weight loss device weekly.
And one of participants who have prediabetes or lifestyle-treated type 2 diabetes, individuals taking Plenity were six times more likely to lose 10 percent of their baseline weight from the end of the study.
What’s more, nearly 60 percent of folks who obtained the Plenity capsules dropped 5 percent of the fat, and 27 percent attained weight loss greater than 10 percent of baseline.
LePort notes once the devices were removed, participants could begin eating normally again, which often contributes to weight gain. The devices could be installed again, but at a price.
At the placebo group, 42 percent of participants lost 5% of baseline body fat, and 15 percent lost 10 percent or more.
The FDA, within their own sweeping approval of Plenity, warns that it must be used alongside diet and exercise. It might also be utilized with other weight loss medications.
Considering that the GLOW study was just six months long, time will tell how effective the device is going to be for people.
Most previously approved devices were for individuals only with a BMI over 30, or people in the obese group.
The analysis was a double-blind, placebo-controlled study. This implies neither the investigators nor the participants knew until after the study had been finished, whether they were getting Plenity or a placebo merchandise.
Gelesis says they are eyeing a late-2019 limited launch with a nationwide release of their product in 2020.
Plenity, created by Boston biotech firm Gelesis, is a hydrogel capsule made with a proprietary mix of cellulose (a form of fiber) and citric acid.
Inside each capsule the two ingredients form a three-dimensional hydrogel matrix. Once in the stomach, the capsules break apart, exposing the matrix to water. Every one of the cells that are hydrogel may absorb up to 100 times its weight, growing in size to occupy space in the stomach and intestines.
“The best technique for fiber supplements would be to consume extra water, which incidentally can aid with weight reduction,” she said.
The FDA has approved a new weight loss aid that develops in your stomach that will assist you feel full with less food. Getty Images
After you consume, the hydrogel matrix goes from the gut, where it breaks down in the intestines. The cells release the water that they absorbed back into your gastrointestinal tract (GI) tract, and then depart the body in a bowel movement.