NCT03686293

A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers

A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers: a Meal Test Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Individuals eating identical meals present high variability in post-meal blood glucose response making comparisons challenging. This study evaluates in 40 healthy and fasted participants whether the postprandial glucose response upon a standardized breakfast is dependent on gut microbial richness. Gastric emptying rate, intestinal transit time, insulin, appetite hormones and measures of the intestinal microbiome and fermentation will also be analyzed in the context of postprandial glucose metabolism.

Detailed description

Elevated blood glucose levels constitute a major risk factor for pre-diabetic and diabetic patients. Postprandial glucose tests have been used for decades to monitor and compare glucose responses. Yet, individuals eating identical meals present high variability in post-meal blood glucose response making comparisons challenging. A recent landmark study showed that the inter-individual variation of postprandial glucose responses was associated with multiple person-specific factors including faecal microbiome factors. Gut microbial richness has for a long time been considered a hallmark of gut health and stability. Furthermore, microbial richness has been associated with colonic transit time, which together with the gastric emptying rate appear to be major determinants of the initial glycaemic response to carbohydrate-containing meals. Therefore, the aim of the study is to investigate whether postprandial glucose responses are associated with gut microbial richness, as well as secondary measures including gastric emptying rate, intestinal transit time and gut microbial composition and fermentation. In an acute-meal study, 40 healthy fasted participants will consume a standardized breakfast including one tablet of paracetamol (for estimating gastric emptying rate) and 300 mL of juice.

Conditions

• Blood Glucose, High

Interventions

Type	Name	Description
OTHER	Standardized breakfast	One tablet of paracetamol (500 mg) and a glass of water (150 mL) is consumed followed by a breakfast consisting of white bread, butter, jam, and juice (300 mL) and

Timeline

• Start date: 2018-10-12
• Primary completion: 2018-12-11
• Completion: 2018-12-11
• First posted: 2018-09-26
• Last updated: 2018-12-13

Locations

1 site across 1 country: Denmark