Blood Glucose, HighMIGLUCOSENCT03686293
A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers
A study testing Standardized breakfast in people with Blood Glucose, High, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, High
- What is being tested?
- Standardized breakfast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Oct 2018to 11 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, 1958
About this study
Official title: A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers: a Meal Test Study
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.
Read the 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
- Being tested
- Standardized breakfast
- Keywords
- Glucose tolerance, Gut microbiota, Microbial richness, Gastric emptying, Metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Standardized breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 min
Secondary outcomes (7)
Fasting (baseline) plasma glucose as a function of gut microbial diversity/richness
We test whether there is an inverse association between fasting plasma glucose and baseline fecal gut microbial richness (cross-sectionally)
Measured: 0 min
Maximum plasma glucose concentration as a function of gut microbial diversity/richness
We test associations between gut microbial diversity/richness and maximum postprandial plasma glucose concentration [Cmax] after a standardised meal including 0.5 g paracetamol.
Measured: 0, 15, 30, 60, 90 and 120 min
Postprandial plasma glucose extremes as a function of gut microbial diversity/richness
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.
Measured: 0, 15, 30, 60, 90 and 120 min
Time to plasma glucose maximum concentration as a function of gut microbial diversity/richness
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
Measured: 0, 15, 30, 60, 90 and 120 min
Postprandial plasma glucose AUC as a function of gut microbial richness/diversity
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
Measured: 0, 15, 30, 60, 90 and 120 min
Postprandial glucose 0-60 min as a function of gastric emptying
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
Measured: 0, 15, 30, 60 min
Gastric emptying and postprandial glucose 0-120 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
Measured: 0, 15, 30, 60, 90 and 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start12 Oct 2018
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose, HighStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Acute meal test
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars O Dragsted, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686293
- Sponsor's protocol ID
- M233
- Acronym
- MIGLUCOSE
- Status last verified
- Dec 2018
- First submitted
- 24 Sep 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers: a Meal Test Study
- ClinicalTrials.gov ID
- NCT03686293
- Acronym / sponsor ID
- MIGLUCOSE / M233
- Conditions
- Blood Glucose, High
- Keywords
- Glucose tolerance, Gut microbiota, Microbial richness, Gastric emptying, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Acute meal test
| Arm | Type | Receives |
|---|---|---|
| Paracetamol and breakfast | Experimental | Other: Standardized breakfastOne tablet of paracetamol (500 mg) and a standardized breakfast will be consumed within 15 minutes one morning upon 10 hours of fasting |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized breakfastOne 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 | Other | Paracetamol and breakfast |
Primary outcome
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
7 secondary outcomes
Fasting (baseline) plasma glucose as a function of gut microbial diversity/richness
Time frame: 0 min
Maximum plasma glucose concentration as a function of gut microbial diversity/richness
Time frame: 0, 15, 30, 60, 90 and 120 min
Postprandial plasma glucose extremes as a function of gut microbial diversity/richness
Time frame: 0, 15, 30, 60, 90 and 120 min
Time to plasma glucose maximum concentration as a function of gut microbial diversity/richness
Time frame: 0, 15, 30, 60, 90 and 120 min
Postprandial plasma glucose AUC as a function of gut microbial richness/diversity
Time frame: 0, 15, 30, 60, 90 and 120 min
Postprandial glucose 0-60 min as a function of gastric emptying
Time frame: 0, 15, 30, 60 min
Gastric emptying and postprandial glucose 0-120 min
Time frame: 0, 15, 30, 60, 90 and 120 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars O Dragsted, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized breakfast in people with Blood Glucose, High, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial plasma glucose at 60 min as a function of gut microbial richness (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.