Among the research findings reported at a joint Chicago meeting of the International Society of Endocrinology and the Endocrine Society was news that a so-called smart pill appears to be a safe and successful aid to shedding excess weight.
According to Medical News Today, the pill, called Gelesis100, is a hydrogel. Its manufacturer is Boston pharmaceutical company Gelesis, a firm founded by a group of individuals that included obesity experts.
Nearly 35 percent of U.S. adults are obese, says the Centers for Disease Control and Prevention. Medical costs associated with the condition were estimated at $147 billion for 2008. In 13 states, obesity prevalence has reached at least 30 percent.
The most common way of determining a person’s weight status is the body mass index (BMI), a simple calculation centered on the ratio of an individual’s height and body weight, according to the Harvard School of Public Health. A healthy BMI for adults is between 18.5 and 24.9. Those whose scores fall between 25.0 and 29.9 are considered overweight. Experts define obesity as having a BMI of at least 30.
Gelesis100 was previously called Attiva. In 1995, it passed a clinical trial of 95 subjects. As Attiva, the substance overall was safe and tolerated well. Minor side effects included nausea, constipation, diarrhea, and stomach ache.
The hydrogel is made up of two food substances that when cross-linked undergo a unique interaction. When an individual consumes water to swallow it, the grain in it turns into gel in the stomach and stretches the walls of the organ. The expansion stretches nerve fibers, sending a signal to the brain that a person’s stomach is full and cannot accommodate any additional food.
Rebranded as Gelesis100, it went through a proof of concept trial. Forty-three subjects received 2.25g of Gelesis100 before mid-day and evening meals. A group of 42 got 3.75g. The control group of 43 subjects took a placebo with cellulose as a bulking agent. All subjects were supposed to reduce their daily intake by 600 calories.
After 12 weeks, individuals in the first group had shed 6.1 percent of body weight. The group that received 3.75g had lost 4.5 percent, while individuals on the placebo were lighter by 4.1 percent. Researchers attribute the poorer results of the group on the higher dosage of Gelesis100 to a lower tolerability. Subjects who lost the most weight during the trial were prediabetics, who shed on average 10.9 percent of their weight.
Boating, flatulence, diarrhea, and abdominal pain were minor side effects experienced in the more recent trial. These minor issues occurred less frequently in the group receiving the smaller dose of the hydrogel.
The manufacturer has confirmed that Gelesis100 will be considered a medical device for regulatory purposes if the FDA approves it.
Vonda J. Sines has published thousands of print and online health and medical articles. She specializes in diseases and other conditions that affect the quality of life.
