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Clinical Trial Summary

According to the data from the [email protected] study, which is part of the National Diabetes Strategy, the prevalence of type 2 diabetes among Spanish population is 13.8%. Diabetic patients suffer from several short and long term complications, which are related to a significant worsen of quality of life and a substantial increase in death rate. In this sense, it is important to prevent the development of Type 2 diabetes. Therefore, it is of high relevance to identify and to treat prediabetic subjects prior to the development of the disease. Many strategies have been implemented to reverse this situation, such as changes in diet and lifestyle, among others. However, it is hard to achieve changes in lifestyle and despite the use of some drugs in this phase of the disease, the problem continues growing. For this reason, new strategies to combat the development of type 2 diabetes are been investigated, such as the use of probiotic formulations. However, at the moment, few studies evidence the effect of probiotics on glycemic regulation. Therefore, an interesting opportunity arises according to the potential ability of probiotic formulation for the control of prediabetes. Considering this background, the main objective of this research is to assess the effect of a new probiotic formulation on glycemic control, insulin resistance and the composition of the fecal microbiota in prediabetic subjects.


Clinical Trial Description

This study is designed as a 12-week, double-blind, randomised, placebo-controlled parallel study. It is focused on prediabetic overweight / obese men and women between 18 and 70 years old. All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research in the University of Navarra for the screening visit and 4 more times during the intervention (week 1, 4, 8 and 12 of study). - Screening visit: evaluation of the inclusion criteria. Volunteers who meet the inclusion criteria are provided with a stool collection kit and a 72 h food record questionnaire. Moreover, they are randomly assigned to one of the two intervention groups: Control group: placebo supplemented; Experimental group: probiotic supplemented. - Clinical investigation day 1 (day 1): The volunteer attend the Nutrition Intervention Unit in fasting state. Each volunteer is asked to provide the stool sample and the 72-hour food record questionnaire. Then, anthropometric, body composition and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. After that, volunteer is provided with the capsules of the study for one month. Finally, fasting blood samples are collected and then an oral glucose tolerance test is carried out and blood samples are taken at 30, 60, 90 and 120 minutes after the ingestion of the glucose solution. - Clinical investigation day 2 (week 4): The volunteer attend the Nutrition Intervention Unit in fasting state. The gastrointestinal symptoms questionnaire is completed and the adherence to the study and to the capsule consumption is assessed. After the measurement of anthropometric, body composition and blood pressure a blood sample is collected. Finally, volunteer is provided with capsules for the next month. - Clinical investigation day 3 (week 8): The volunteer attend the Nutrition Intervention Unit in fasting state. The gastrointestinal symptoms questionnaire is completed and the adherence to the study and to the capsule consumption are assessed. After the measurement of anthropometric, body composition and blood pressure, a blood sample is collected. Finally, the stool collection kit, 72h food record questionnaire and capsules for one month are given to the volunteer. - Clinical investigation day 4 (week 12): The volunteer attend the Nutrition Intervention Unit in fasting state. Each volunteer is asked to provide the stool sample and the 72-hour food record questionnaire. Then, anthropometric, body composition and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire are completed. Finally, fasting blood samples are collected and then an oral glucose tolerance test is carried out and blood samples are taken at 30, 60, 90 and 120 minutes after the ingestion of the glucose solution. One month later, the online version of the gastrointestinal symptoms questionnaire is send to each volunteer in order to asess any gastrointestinal symptom after stopping capsule consumption. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04863313
Study type Interventional
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact María Jesús Moreno Aliaga, PhD
Phone +34 948425600
Email [email protected]
Status Recruiting
Phase N/A
Start date March 11, 2021
Completion date March 15, 2022

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