With the soaring numbers of expanding waistlines everyone is looking for safe weight-loss strategies. A new analysis is predicting that by 2030, 48.9% of adults in the United States will be obese and 24.2% will be severely obese.
A person with a body-mass index (BMI– a measure of weight relative to height) of 30 or above is considered obese. Having a BMI at or above 35 is regarded as severe obesity.
The average adult male in the U.S. who stands at 5′ 9″ is obese if he weighs more than 202 pounds and severely obese at more than 236 pounds. The comparable thresholds for obesity and severe obesity for the average U.S. female, at 5′ 4″, are 174 and 203.
Being overweight or having obesity increases the risk for numerous health problems, including cardiovascular disease, diabetes, joint and bone issues, and even some types of cancer. As a result there’s been some recent excitement over a new FDA approved medication due out this fall- Plenity.
- Plenity is a pill, but it’s considered a device by the FDA.
- The pill works by releasing particles into the digestive system that expand when a person drinks water before a meal.
What Is Plenity?
Plenity is synthesized from two naturally derived ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine. The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity (firmness) of plant-based foods (e.g., vegetables) without caloric value. The gel particles mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine, promoting satiety and fullness. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. The water is then released and reabsorbed by the body. Plenity particles are eliminated through normal bowel movements (and are not absorbed).
After taking three capsules before lunch and three more before dinner, it’s important to drink 16 ounces of water and then wait 20 minutes before having the next meal, or choking can occur.
One of the biggest challenges with trying to lose weight is the feeling you’re being deprived, so in addition to diet and exercise this may help people lose more weight than they would otherwise on their own.
It’s also approved for adults who have a body mass index as low as 25 all the way to 40, which means it can be prescribed for those who are overweight (BMI of 25 to 29) not just patients with obesity (BMI 30.0 and higher).
How Does Plenity Work?
Inside the porcine gelatin capsules of Plenity are thousands of absorbent hydrogel particles, which are made of cellulose and citric acid. The manufacturer says when consumed with multiple glasses of water, the particles can expand to 100 times their original weight. While in the stomach and small intestine, the particles make a person feel full before a meal, which makes them less inclined to overeat.
Plenity is considered a device and not a drug because the expanded particles pass through a person’s digestive system and are excreted during a bowel movement. It isn’t absorbed into the bloodstream during any part of the process, so the federal government treats the particles like parts of a machine rather than a chemical that affects the way a person’s body operates.
The Evidence
A recent clinical study published in the journal Obesity, found six out of 10 participants on Plenity lost increased pounds- losing 10% of their body weight or more in six months. On average, they lost 22 pounds and 3.5 inches from their waist and 14% lost 30 pounds or more. But this was a small sample size. Most medications seeking to get FDA approval need thousands of patients for their clinical trials. While this is a device not a medication, it’s concerning it was not held to the same standard.
It’s important to note this clinical trial also counseled nutritional and lifestyle recommendations. All the participants were encouraged to engage in healthier behavior, including participating in regular, moderate physical activity- equivalent to a 30-minute walk each day- and counseled to help reduce their average daily caloric intake by 300 calories. It is unclear whether it will be as effective without these additions.
Side Effects
Most adverse effects were mild or moderate in intensity. They primarily consisted of abdominal distension, abdominal pain, bloating, irregular bowel movements, changes in frequency and consistency of bowel movements, constipation, cramping, belching, diarrhea, indigestion, gastroesophageal reflux disease (GERD), vomiting, gas, difficulty swallowing, dehydration and oddly enough-weight gain.
Cautions
- Contact a healthcare provider immediately if a severe or continued adverse event occurs. If a severe allergic reaction, severe abdominal pain, or severe diarrhea occurs, stop using.
- Use with caution if there’s underling symptoms of dysphagia- trouble swallowing- or active gastrointestinal conditions such as ulcers, GERD, or heartburn
- Avoid using if you have the following conditions:
- Esophageal anatomic anomalies, including webs, diverticuli, and rings.
- Suspected strictures (such as with Crohn’s disease).
- Complications from prior gastrointestinal surgery that could affect GI transit and motility.
- Plenity should be taken under the direction of a heath care provider as part of a structured weight loss program. Failure to adhere to prescribed dietary and exercise instructions may result in failure to lose weight.
- Pregnancy
- History of allergic reaction to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium oxide
- It is unclear how it may impact other medications
Is It Effective?
Plenity is not a magical weight loss pill. Even in testing, people who took Plenity were also required to undergo a weight management program of nutrition, diet, and exercise. It does not replace the basic foundations to any long term, healthy, weight loss program.
Because Plenity doesn’t ultimately change a person’s long-term habits -such as what they eat and how often they exercise – only time will tell if it’s any better than what is already on the market i.e. Benefiber, Metamucil, Glucomannan, or just eating high fiber foods and drinking more water.
Sources:
-gelesis.com/2019/04/14/gelesis-granted-fda-clearance-to-market-plenitytm-a-new-prescription-aid-to-weight-management/
-ncbi.nlm.nih.gov/pmc/articles/PMC5233838/
-pubmed.ncbi.nlm.nih.gov/30421844/
-healthline.com/health-news/weight-loss-pill-plenity-not-available-until-fall-2020
-rxlist.com/plenity-side-effects-drug-center.htm#overview
-.myplenity.com/?gclid=CjwKCAjwiMj2BRBFEiwAYfTbCgvYb_Vg1zKGuzNWhXuDEy9PGNuRqe2763pYyEG7a6nS8zAqYSbxHhoCMcQQAvD_BwE