NCT03686293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

October 12, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

September 24, 2018

Last Update Submit

December 12, 2018

Conditions

Blood Glucose, High

Keywords

Glucose toleranceGut microbiotaMicrobial richnessGastric emptyingMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Postprandial plasma glucose at 60 min as a function of gut microbial richness

    We test whether there is an inverse association between baseline fecal gut microbial richness and postprandial plasma glucose at 60 min after a standardised meal including 0.5 g paracetamol

    60 min

Secondary Outcomes (7)

  • Fasting (baseline) plasma glucose as a function of gut microbial diversity/richness

    0 min

  • Maximum plasma glucose concentration as a function of gut microbial diversity/richness

    0, 15, 30, 60, 90 and 120 min

  • Postprandial plasma glucose extremes as a function of gut microbial diversity/richness

    0, 15, 30, 60, 90 and 120 min

  • Time to plasma glucose maximum concentration as a function of gut microbial diversity/richness

    0, 15, 30, 60, 90 and 120 min

  • Postprandial plasma glucose AUC as a function of gut microbial richness/diversity

    0, 15, 30, 60, 90 and 120 min

  • +2 more secondary outcomes

Other Outcomes (23)

  • Saliva microbiome

    0 min

  • Fecal microbiome

    0 min

  • Urine metabolome

    0, 0-150 min

  • +20 more other outcomes

Study Arms (1)

Paracetamol and breakfast

EXPERIMENTAL

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

Other: Standardized breakfast

Interventions

Standardized breakfastOTHER

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

Paracetamol and breakfast

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

Location

Study Officials

  • Lars O Dragsted, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Acute meal test
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

October 12, 2018

Primary Completion

December 11, 2018

Study Completion

December 11, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

DK(1)