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Completed

NCT Number: NCT03686293

A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers

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.

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Key information

Conditions

Blood Glucose, High

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

standardized breakfast

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

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Technical University of Denmark

Registry information

Official study title

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

Acronym: MIGLUCOSE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2018
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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