Effect of a Probiotic on the Glycemic Profile and the Fecal Microbiota of Prediabetic Subjects (PREDIABETCARE)

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.

Conditions

• PreDiabetes
• Overweight and Obesity

Interventions

DIETARY_SUPPLEMENT

Probiotic

Experimental group will consume one probiotic capsule every day during 12 weeks at breakfast.

DIETARY_SUPPLEMENT

Placebo

Placebo group will consume one placebo capsule every day during 12 weeks at breakfast.

Sponsors & Collaborators

• GENBIOMA Aplicaciones SL

  collaborator UNKNOWN

• Gobierno de Navarra/FEDER

  collaborator UNKNOWN

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• María Jesús Moreno Aliaga, PhD · University of Navarra

• Carlos González Navarro, PhD · University of Navarra

• Pedro González Muniesa, PhD · University of Navarra

• Idoia Ibero Baraibar, PhD · University of Navarra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-11

Primary Completion

2022-07-20

Completion

2022-12-09

Countries

• Spain

Study Locations