NCT02694172

Human Faecal Microbiota in Type 2 Diabetes

Analysis of the Diversity of Faecal Bacteria in Healthy and Type 2 Diabetic Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of the clinical trial is to investigate whether overweight type 2 diabetic patients have a different fecal microbiota profile compared with age, gender, BMI matched subjects and with lean healthy subjects before and after the consumption of fiber rich cereal bars.

Detailed description

Gut microbiota refers to the bacterial communities in the gastrointestinal tract. The diversity and quantity of bacteria vary depending on age of the individuals, daily diet and the segment of the intestine, which makes the gut microbiota one of the most complex bacterial ecosystems known to men. In general, over trillions of bacteria reside in human gut. Recent evidence indicates that gut microbiota could be involved in host metabolism by multiple pathways leading to the development of obesity and type 2 diabetes. Increased fat storage or obesity has become one of the leading public health issues in many developed and developing countries. However, it is not clear whether type 2 diabetes is associated with a unique gut microbiota profile. Therefore, the primary objective of the study is to compare the fecal microbiota of overweight type 2 diabetic subjects to that of age, gender and BMI matched subjects as well as with lean non-diabetic subjects. In addition, the investigators hypothesize that microbiota modifications with consumption of fiber rich food products can improve the metabolic outcomes of type 2 diabetics. To test this hypothesis, the investigators plan to provide each overweight participant with two cereal bars per day for 4 weeks. Anthropometric measurements and plasma parameters as well as the fecal microbiota will be determined.

Conditions

• Type 2 Diabetes
• Healthy
• Overweight

Interventions

Type	Name	Description
OTHER	Fiber rich cereal bars	Two cereals per day and per subject for 4 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-06-01
• Completion: 2011-04-01
• First posted: 2016-02-29
• Last updated: 2016-02-29