In a preliminary study, Attiva, increased the post-meal feeling of satiety and reduced hunger between meals.
In a preliminary study of 95 individuals, Attiva, a novel superabsorbent biodegradable hydrogel made up of cellulose derivatives, increased the post-meal feeling of satiety and reduced hunger between meals, according to new research reported here at the American Association of Clinical Endocrinologists (AACE) 19th Annual Meeting and Clinical Congress.
The product, composed entirely of cellulose derivatives, was well-tolerated, Hassan M. Heshmati, MD, chief medical officer of Gelesis, Inc., Boston, Massachusetts, told reporters at a media briefing.
If the results of the study, which was done at the Gemelli Hospital in Rome and the University of Salento, Lecce, Italy, under the auspices of the National Research Council of Italy, Naples, are confirmed in other, long-term studies, Attiva will be a promising new anti-obesity agent and may represent a non-invasive alternative to bariatric surgery, without the complications, Heshmati said.
The study included 73 females and 22 males, mean age 41 years (range 19 to 67 years) with a mean body mass index (BMI) of 31.1 (range 18.0 to 55.9). Twenty-one subjects had a normal BMI, 22 were overweight, and 52 were obese.
The subjects consumed 2g of Attiva or placebo before breakfast, lunch, and dinner, in a double-blind, cross-over fashion at three-day intervals. They ate their usual meals at home.
Satiety was assessed with a self-administered questionnaire immediately, 30 minutes, and 60 minutes after each meal.
The study found that Attiva significantly increased post-prandial feeling of satiety at 30 minutes after breakfast and dinner — what Heshmati referred to as the “first-meal effect” – and at 60 minutes after lunch and dinner, compared with placebo – the second meal effect.
The mean ± SD for the satiety scores with Attiva compared with placebo at 30 minutes were 1.85 ± 0.93 versus 1.63 ± 0.95 (P = 0.037), 1.84 ± 1.14 versus 1.66 ± 0.87 (P = 0.071), and 1.98 ± 0.97 versus 1.70 ± 1.01 (P = 0.004), for breakfast, lunch, and dinner, respectively. At 60 minutes, the mean ± SD for the satiety scores with Attiva compared with placebo were 2.13 ±1.00 versus 2.12 ± 0.83 (P = 0.960), 2.35 ± 1.06 versus 2.07 ± 0.86 (P = 0.007), and 2.46 ± 1.12 versus 2.15 ± 0.99 (P = 0.006), for breakfast, lunch, and dinner, respectively.
We also noticed that the administration of Attiva before lunch caused a decrease in the feeling of hunger before dinner; this is what we call the second effect.
Asked about the side effects with Attiva, Heshmati said they were mostly gastrointestinal. The most common symptom was nausea which occurred in 7.4% of subjects “which is within the range of obese subjects treated with placebo.”
Attiva is taken as a capsule with a glass of water. When it reaches the stomach, the active particles are released and the water causes the hydrogel particles to swell and take up stomach volume.
Just as in bariatric surgery, this reduction in stomach volume causes people to eat less. “The difference is that bariatric surgery is a highly invasive procedure, whereas Attiva is completely non-invasive. Attiva also slows the rate of gastric emptying, another mechanism known to increase satiety, Heshmati said.