The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.
The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine. In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes. The key objective of this randomized, placebo-controlled study is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects. Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of Intestinimonas will be compared with the low-dose tested in the initial double-blind Randomised Controlled Trial (RCT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
Capsules containing microbiota (Intestinimonas)
Placebo capsules are identical to the active treatment
University Piemonte Orientale
Vercelli, Italy
Insulin sensitivity
as measured by Homeostatic Model Assessment (HOMA) - index
Time frame: 12 weeks
Concentration of Fasting glucose
as measured by Glucose in plasma
Time frame: 12 weeks
Level of 2-hour blood glucose Area Under the Curve (AUC)
as measured by standard Oral Glucose Tolerance Test (OGTT)
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.