Extrait

Background and study aims The hormone insulin is produced by β-cells in part of the pancreas known as the Islet of Langerhans. These β-cells can deteriorate and fail to release insulin due to age and lifestyle factors which can lead to the development of type 2 diabetes. Resistant starches are found within certain food products, particularly fruits, vegetables and whole grains, and are believed to be beneficial to β-cells. This is because the resistant starch is not digested and is instead used by bacteria within the gut. The bacteria ferment the resistant starch to produce short chain fatty acids (SCFAs), which are believed to improve β-cell function. We are investigating the effects of food products containing resistant starches found naturally in peas. The aim of this study is to see if resistant starch from peas can improve β-cell function. Who can participate? Patients aged between 18-65 with body mass index (BMI) of 20-35 kg/m2 What does the study involve? Participants first meet one of the research doctors who interview them and conduct a general physical examination. Participants then undergo two separate 28-day dietary supplementation periods in a random order. In each supplementation period participants are provided with common food products (bread, soup, yoghurt, fruit juice, biscuit bars) supplemented with resistant starches or food products with no supplementation. Participants are asked to eat these food products in addition to their normal diet for 28 days. Before and at the end of each 28-day supplementation period participants attend two study visits on consecutive days at the Clinical Investigation Unit, Hammersmith Hospital to assess their β-cell function and insulin sensitivity. There is a break of 28 days between finishing the first dietary supplementation period and starting the second supplementation period. What are the possible benefits and risks of participating? Some of the procedures in this study, such as the recording of your weight, height and blood pressure, present no risk. Other procedures, such as taking blood samples, can cause mild discomfort. The risks of taking a blood sample include: slight discomfort when the needle is inserted and possible bruising and a localised infection. These procedures will only be carried out by experienced doctors under aseptic conditions to minimise all these risks. There are no major side effects associated with eating foods containing resistant starch; however, some people may experience mild abdominal bloating. Where is the study run from? Imperial College of Science, Technology and Medicine (UK) When is the study starting and how long is it expected to run for? April 2015 to April 2017 Who is funding the study? Biotechnology and Biological Sciences Research Council (UK) Who is the main contact? Dr Edward Chambers

Critère d'inclusion

• Topic: Metabolic and endocrine disorders; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes)

Liens

• ictrp
• isrctn