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A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers (MIGLUCOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686293
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Professor Lars Ove Dragsted, University of Copenhagen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Blood Glucose, High Other: Standardized breakfast Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Acute meal test
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers: a Meal Test Study
Actual Study Start Date : October 12, 2018
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Glucose

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Postprandial plasma glucose at 60 min as a function of gut microbial richness [ Time Frame: 60 min ]
    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


Secondary Outcome Measures :
  1. Fasting (baseline) plasma glucose as a function of gut microbial diversity/richness [ Time Frame: 0 min ]
    We test whether there is an inverse association between fasting plasma glucose and baseline fecal gut microbial richness (cross-sectionally)

  2. Maximum plasma glucose concentration as a function of gut microbial diversity/richness [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    We test associations between gut microbial diversity/richness and maximum postprandial plasma glucose concentration [Cmax] after a standardised meal including 0.5 g paracetamol.

  3. Postprandial plasma glucose extremes as a function of gut microbial diversity/richness [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    We test associations between gut microbial diversity/richness and the difference from the postprandial plasma glucose peak to the glucose level after 60 min or at the postprandial minimum between 30-120 min after a standardised meal including 0.5 g paracetamol.

  4. Time to plasma glucose maximum concentration as a function of gut microbial diversity/richness [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    We test associations between gut microbial diversity/richness and the time to the postprandial plasma glucose maximum concentration [Cmax] after a standardised meal including 0.5 g paracetamol

  5. Postprandial plasma glucose AUC as a function of gut microbial richness/diversity [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    We test associations between gut microbial diversity/richness and AUC 0-120 min for plasma glucose after a standardised meal including 0.5 g paracetamol

  6. Postprandial glucose 0-60 min as a function of gastric emptying [ Time Frame: 0, 15, 30, 60 min ]
    We test associations between gastric emptying measured as AUC 0-60 min of postprandial paracetamol concentration profiles in blood and postprandial plasma glucose at 60 min during a standardised meal including 0.5 g paracetamol

  7. Gastric emptying and postprandial glucose 0-120 min [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    We test associations between gastric emptying measured as AUC 0-120 min of postprandial paracetamol concentration profiles in blood and postprandial plasma glucose AUC 0-120 min during a standardised meal test with intake of 0.5 g paracetamol


Other Outcome Measures:
  1. Saliva microbiome [ Time Frame: 0 min ]
    Determination of saliva microbiome composition at baseline

  2. Fecal microbiome [ Time Frame: 0 min ]
    Determination of fecal microbiome composition at baseline

  3. Urine metabolome [ Time Frame: 0, 0-150 min ]
    Urine metabolome as determined by untargeted metabolic profiling by LC-QTOF of all urine samples collected before the meal and postprandially from 0-150 min

  4. Fecal metabolome [ Time Frame: 0 min ]
    Fecal metabolome as determined by untargeted metabolic profiling by LC-QTOF of ethanolic extracs from all baseline fecal samples collected before the intervention

  5. Plasma metabolome [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Plasma metabolome as determined by untargeted metabolic profiling by LC-QTOF of ethanolic extracs from all fasting and postprandial plasma samples

  6. Glucose metabolism [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Plasma glucose measured in fasting and postprandial plasma samples

  7. Plasma Insulin [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Plasma insulin measured in fasting and postprandial plasma samples

  8. Plasma short-chain fatty acids [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Plasma short-chain fatty acids measured in fasting and postprandial plasma samples

  9. Lipid metabolism [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Bile acids in blood (fasting and postprandially) and in feces (baseline)

  10. Glucagon like peptide 1 (GLP-1) [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Plasma glucagon like peptide 1 (GLP-1) measured in fasting and postprandial plasma samples

  11. Peptide tyrosine tyrosine (PYY) [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    PYY measured in fasting and postprandial plasma samples

  12. Ghrelin [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Ghrelin measured in fasting and postprandial plasma samples

  13. Gastric inhibitory polypeptide (GIP) [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    GIP measured in fasting and postprandial plasma samples

  14. Cholecystokinin (CCK) [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    CCK measured in fasting and postprandial plasma samples

  15. Gastric emptying [ Time Frame: 0, 15, 30, 60, 90 and 120 min ]
    Gastric emptying measured as postprandial paracetamol concentration profiles in blood

  16. Postprandial breath exhalation [ Time Frame: 0, 60, 150 min ]
    Fasting and postprandial breath hydrogen/methane exhalation

  17. Feces short-chain fatty acids [ Time Frame: 0 min ]
    Feces short-chain fatty acids measured in all fecal samples collected at baseline

  18. Feces pH [ Time Frame: 0 min ]
    Feces pH measured in all fecal samples collected at baseline

  19. Feces energy [ Time Frame: 0 min ]
    Feces energy measured in all fecal samples collected at baseline by bomb calorimetry

  20. Stool consistency [ Time Frame: 0 min ]
    Consistency of stool sample collected at baseline assessed by the Bristol stool scale

  21. Intestinal transit time [ Time Frame: Before intervention ]
    Participants are instructed to observe the time it takes corn to travel through their gastrointestinal system five days prior to the intervention

  22. Defecation patterns [ Time Frame: Before intervention ]
    Average number of poops per day and average stool consistency as assessed by Bristol stool scale

  23. Gastrointestinal symptoms [ Time Frame: Before intervention ]
    Gastrointestinal symptoms measured on a 10 cm visual analog scale (VAS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686293


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Technical University of Denmark
Investigators
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Principal Investigator: Lars O Dragsted, PhD University of Copenhagen
More Information
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Responsible Party: Professor Lars Ove Dragsted, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03686293    
Other Study ID Numbers: M233
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Lars Ove Dragsted, University of Copenhagen:
Glucose tolerance
Gut microbiota
Microbial richness
Gastric emptying
Metabolomics