“Similar to taking psyllium mixed with water to make a fiber-rich drink to keep you fuller longer, this brand new product appears to work the identical manner,” said Julie Upton, MS, RD, co-founder of Appetite for Health.
“Generally speaking, I believe these all some type of gimmick the patient uses to take in calories, as in the long run, it comes down to calories. You are going to gain weight Should you take in too many. Should you take in too small, you’re going to lose weight,” LePort explained.
The preliminary research on Plenity do reveal promising results, but long-term results are always the key to all weight loss products or plans.
Bottom line Including people in the overweight and BMI types.
“In the past [there are ] multiple apparatus to set in your stomach to make you feel like there’s food on your stomach so you don’t want to consume more,” said 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 outcomes of a 2018 research from the journal Obesity to Provide the thumbs up for Plenity.
At the close of the study period, participants who were using the Gelesis weight loss aid lost 6.4 percent of the baseline weight versus 4.4 percent in the placebo group. While not a massive difference, it is statistically significant.
“They’ve always had some problem. Either they eroded the stomach or they passed into the intestines and they couldn’t get it out,” he said.
Because the body doesn’t absorb the hydrogel — it moves through the gut and outside the end of the GI tract — that the FDA believes it to be a”device,” not a medication.
How does Plenity work?
LePort points out that Plenity, despite not having an established price point nevertheless, is very likely to be many times less costly than surgery.
“If this device reduces the number of calories you’re able to take within an 24-hour interval, then you will lose weight up to the point at which you’re taking in the right amount of calories,” he added.
The outcome is that you feel full and have less room for meals, thus you’re very likely to consume less.
Individuals taking Plenity were prone to experience GI issues — nausea, bloating, abdominal pain, and gas — than people taking the placebo, but the percentages were quite similar.
For example, 12.6 percent of individuals taking Plenity reported nausea compared to 8.5 percent of placebo consumers; 11.7 percent of Plenity users reported bloating compared to 6.6% of placebo users.
And one of participants who have prediabetes or lifestyle-treated type 2 diabetes, individuals taking Plenity were six times more likely to shed 10 percent of their baseline weight by the end of the study.
What is more, nearly 60 percent of people who took the Plenity capsules dropped 5 percent of their weight, and 27 percent attained weight loss greater than 10 percent of baseline.
LePort notes that once the devices were removed, participants could begin eating normally again, which frequently leads to weight gain. The devices could be installed but at a price.
In the placebo group, 42 percent of participants lost 5% of baseline body fat, and 15 percent dropped 10 percent or more.
The FDA, in their own sweeping approval of Plenity, cautions that it has to be used alongside exercise and diet. It may also be utilized together with other weight loss drugs.
Since the GLOW analysis was only six months , time will tell how successful the device will be for individuals.
Most formerly approved devices were for individuals only with a BMI above 30, or those in the obese group.
The study proved to be a double-blind, placebo-controlled research. This means the investigators nor the participants knew whether they were getting a placebo product or Plenity until after the analysis was finished.
Gelesis says they are eyeing a late-2019 limited launch with a nationwide launch of their merchandise in 2020.
Plenity, made by Boston biotech company Gelesis, is a hydrogel capsule created out of a proprietary blend of cellulose (a type of fiber) and citric acid.
Inside every capsule the 2 ingredients form a three-dimensional hydrogel matrix. The capsules break apart, exposing the matrix into water. Each of the cells that are hydrogel can consume up to 100 times its weight, growing to occupy space in the stomach and intestines.
“The key to fiber supplements is to drink extra water, which incidentally can help with weight loss,” she said. Getty Images
Once you consume, the hydrogel matrix moves from the stomach, where it breaks down in the intestines. The cells discharge the water that they absorbed back into your gastrointestinal tract (GI) tract, then depart the body in a bowel movement.