GLUCOCAPS
Zein nanoparticles for blood glucose control
♦ Projects at partnership or for transfer of knowledge
♦ reference letter: 0011-1365-2021-000224
partnership between NUCAPS and the University of Navarra's research center in Nutrition
The high prevalence of Diabetes mellitus subject 2 (DM2) and its role as a risk factor in the development of other diseases, make this pathology a public health problem. In addition, patients with DM2 present numerous short- and long-term complications during their lifetime. Neuropathies, retinopathies, renal involvement, coronary artery disease, peripheral vascular disease, etc., entail a very significant loss of quality of life and a risk of death twice as high as in people without this disease. All this means that this status represents a great social burden and an important health care expense .
In this sense, it would be very useful to be able to act in the moments prior to the development of the disease such as in the status of prediabetes, since according to the most recent data available, the conversion of this status to DM2 is around 18% per year and it has even been shown that these people have an increased risk of cardiovascular disease and even death before developing diabetes. However, achieving changes in lifestyle and habits is truly complex and despite the use of some drugs at this stage of the disease, the problem continues to grow. In this context, the use of zein nanoparticles for the prevention of development diabetes subject 2 is a novel element.
In recent years, zein nanoparticles have been proposed and used as oral delivery systems for drugs and bioactive compounds, demonstrating an important capacity to increase the oral bioavailability of compounds ascribed to group II and group IV of the biopharmaceutical classification system. These empty nanoparticles (without containing any biologically active compound) were recently shown to have a hypoglycemic effect in vivo. These results would be due to the stimulatory effect of zein nanoparticles interacting with L cells in the intestine and inducing the release of GLP-1 (glucagon-like peptide subject 1). This opens the door to the use of natural physiological mechanisms that control glycemic metabolism. The fact that these nanoparticles can reach certain areas of the gastrointestinal tract to specifically induce the secretion of GLP-1 by L cells in the intestine opens the door to the use of natural physiological mechanisms that control glycemic metabolism.
Therefore, the present project aims to validate the previous results obtained in animals, through a nutritional intervention study in humans and to advance in the knowledge of its potential use in the dietary management of prediabetic people and/or people diagnosed with diabetes subject 2.
- To study the evolution of biochemical variables related to glycemic metabolism: Fructosamine, basal glucose, basal insulin, C-peptide and evolution of serum GLP-1 levels after 60 minutes of glucose consumption.
- To evaluate the evolution of biochemical variables related to lipid metabolism: total serum cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides.
- To assess the evolution of variables related to liver function: transaminases (ALT/AST).
- To analyze the evolution of the hemogram.
- To evaluate the evolution of anthropometric variables (weight, height, waist and hip) and body composition (body mass index, fat mass, fat-free mass, muscle mass, water and bone mass), to rule out that the observed changes are due to relevant variations in anthropometric parameters.
- Assess adherence to treatment and adverse events.
In order to achieve the proposed objectives, we propose to carry out a nutritional intervention study in 60 volunteers with prediabetes, according to outline:
This business has received a financial aid co-financed 50% by the European Regional Fund development through the ERDF Operational Program 2014-2020 of Navarra.