A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers

NCT ID: NCT03686293

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-12
• Study Completion Date: 2018-12-11

Brief 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

Keywords

Glucose tolerance; Gut microbiota; Microbial richness; Gastric emptying; Metabolomics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Paracetamol and breakfast

One tablet of paracetamol (500 mg) and a standardized breakfast will be consumed within 15 minutes one morning upon 10 hours of fasting

Group Type: EXPERIMENTAL

Standardized breakfast

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI < 27
• Willing to eat lentils, tomatoes, spaghetti, bread, butter, strawberry jam, and drink juice
• Known ability to tolerate paracetamol
• No current use of medication (oral contraceptive pill and mild antidepressants is allowed)
• Did not take antibiotics, diarrhoea inhibitors and laxatives in the 6 previous months
• Willing to collect and deliver a faecal sample on the intervention day
• Willing to eat corn and fill out a self-reported corn-intestinal transit time questionnaire
• Willing to consume a paracetamol tablet (500 mg paracetamol)

Exclusion Criteria

• Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
• Pregnant or lactating women
• Suffering from irritable bowel disease (IBS), small intestine bacterial overgrowth (SIBO) or inflammatory bowel disease (IBD)
• Current chronic or infectious disease
• Current diagnosis of diabetes
• Blood donations within 3 months before participating in the current trial or participation in other scientific experiments
• Frequent intake of painkillers (paracetamol)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technical University of Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Professor Lars Ove Dragsted

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars O Dragsted, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, , Denmark

Countries

Denmark

Other Identifiers

M233

Identifier Type: -

Identifier Source: org_study_id