Effect of a Probiotic on the Glycemic Profile and the Fecal Microbiota of Prediabetic Subjects (PREDIABETCARE)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Overweight and Obesity
- Prediabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04863313
- Collaborators
- GENBIOMA Aplicaciones SL
- Gobierno de Navarra
- Investigators
- Principal Investigator: María Jesús Moreno Aliaga, PhD University of Navarra Study Director: Carlos González Navarro, PhD University of Navarra Study Chair: Pedro González Muniesa, PhD University of Navarra Study Chair: Idoia Ibero Baraibar, PhD University of Navarra