Effect of a Probiotic on the Glycemic Profile and the Fecal Microbiota of Prediabetic Subjects (PREDIABETCARE)
Condition: PreDiabetes; Overweight and Obesity
MeSH terms: Overweight; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      According to the data from the Di@bet.es 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.
    

Detailed 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.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Experimental group will consume one probiotic capsule every day during 12 weeks at breakfast.; Placebo group will consume one placebo capsule every day during 12 weeks at breakfast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prediabetes; Obesity and overweight; Glycated hemoglobin; Blood glucose; Fecal microbiota; Probiotic