A prospective randomized controlled crossover trial to test the effects of a delayed-release nutrient pill on several appetite-suppressing hormones.
Delivery of nutrients into the intestine is associated with increased levels of GLP-1, an appetite-suppressing hormone. Decreased appetite may be a favorable outcome in individuals with obesity and related comorbidities. The researchers hypothesized that a pill designed to release nutrients rapidly into the small intestine stimulates the release of GLP-1 and several other appetite-suppressing hormones, mimicking what happens after gastric bypass surgery. This trial aimed to evaluate the effects of the ingestion of a single dose of a nutrient pill on the circulating levels of GLP-1 and appetite in patients with obesity and type 2 diabetes.
A nutrient pill was formulated to deliver 200 kcal of nutrients several times a day for several months directly to the small intestine. The ethyl cellulose-alginate GRAS coating was used as the coating to provide enteric protection in the acidic PH of the stomach while also enabling the release of nutrients in the upper alkaline intestine. The nutrient was ingested with non-caloric tonic water to maintain the integrity of the coating in the stomach.
This was a prospective randomized crossover trial. The study included a total of 19 participants that completed both study visits, and this was the sample size required to detect the outcome with a power of 80% and a 2-sided alpha of 0.05. Each participant underwent two 3-h meal tolerance tests (MTT) 1-4 weeks apart, once with the delayed-release nutrient pill and another time with unformulated macronutrient. Participants were aged 18-65 years, BMI > 27 kg/m2 and had a diagnosis of type 2 diabetes. Two 4 ml blood samples were collected from the participants 5 minutes apart to establish a baseline. Immediately afterward, participants were given either the delayed-release nutrient pill or the unformulated nutrient with tonic water. Blood samples were then collected every 15 minutes for 3 hours. The outcomes of the study were the levels of circulating GLP-1, C-peptide, insulin, glucose, satiety and any adverse effects.
The researchers observed that it took a mean of 103 minutes after consumption of the pill for participants to reach peak levels of GLP-1 compared with a mean of 58 minutes after the use of the unformulated nutrient (P=.03). However, there was a decline in GLP-1 levels after 90 minutes with the unformulated nutrient while it remained high and continued to rise with the delayed-release nutrient pill. Furthermore, the maximal concentration of glucose, C-peptide and insulin were significantly lower with the delayed-released tablet compared with the unformulated nutrient.
The site, length, and rate of nutrient exposure were not assessed in this study, which was one of the limitations. In addition to that, in vitro gastrointestinal simulation testing was not available. Numerous studies in this field are required to verify the results.
In conclusion, the findings of this study demonstrate that GLP-1 release can be delayed based on the nutrient formulation and can help patients with obesity to control appetite and hyperglycemia.
- This was a prospective randomized crossover trial aimed to evaluate the effects of ingestion of a single dose of a nutrient pill on the circulating levels of GLP-1 and appetite control in patients with obesity and type 2 diabetes.
- The study included a total of 19 patients who were able to complete both visits. Participants were aged between 18-65 years and had obesity with a diagnosis of type 2 diabetes.
- The researchers observed that it took longer after consumption of the formulated pill for participants to reach peak levels of GLP-1 compared with the unformulated nutrient, but levels continued to rise after the three h test. The maximal concentration of glucose, C- peptide and insulin was significantly lower with the formulated pill compared with the unformulated powder.
Beale E, et al. Development of a delayed-release nutrient for appetite control in adults with obesity and type 2 diabetes and initial clinical testing in a single randomized controlled trial. Nutrition & Diabetes. 2019 Jul; 9 (20).
Nadeen Ayad, BCPS, PharmD candidate, Skaggs School of Pharmacy, University of Colorado.