Diet, HealthyPRIMANCT04804319
Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut
An observational study of Diet, Healthy and Metabolic Disease, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Metabolic Disease
- What is being tested?
- 9-days habitual diet
- How many people
- 63 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Apr 2021to 29 Nov 2021
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- 18.5-30.0 kg/m2 BMI
- Willing to daily collect a urine and stool sample at home and able to store them in their own freezer in a provided containers throughout the 9-days trial
- Willing to eat sweet corn and report corn-intestinal transit time questionnaire
- Willing to record 9 days dietary intake and defecation pattern
- Willing to have blood samples drawn two times
- Owns a device with access to the internet and is willing to use myfood24 platform
- Known ability to tolerate paracetamol and willing to consume ½ paracetamol tablet dissolved in water (250mg)
- Willing to eat rye bread, butter, jam, egg, yoghurt, berries and nuts
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 inflammatory bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO) or inflammatory bowel diseases (IBD)
- Intake of antibiotics, diarrhea inhibitors and laxatives ˂ 1month
- Current chronic or infectious diseases
- Diagnosis of diabetes
Show all 13Show fewer
- History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- Frequent intake of painkillers or other medication (mild antidepressants and contraceptive pills are allowed)
- Concurrent participation in another trial
- Additional exclusion criteria for the SmartPill sub-study:
- Intake of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids)
- Intake of medications potentially altering the gastrointestinal motility (prokinetics, antiemetic agents, anticholinergic agents, narcotic analgetics, nonsteroidal anti-inflammatory drugs)
- Dysphagia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Nutrition, Exercise and Sports
Copenhagen, 1958
About this study
Official title: Towards Personalized Dietary Recommendations Based on the Interaction Between Diet, Microbiome and Abiotic Conditions in the Gut
The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.
Read the detailed description
The study is a 9-day trial including 85 healthy adults in age between 18 and 75. The participants will throughout the trial register their dietary intake, gastrointestinal symptoms including stool frequency and Bristol stool scale, physical activity, and medicine and supplements intake. Participants will on day 3 and day 5, respectively, consume sweet corns to estimate intestinal transit time by the time it takes sweet corn to travel through the gastrointestinal system. Furthermore, the participants will collect daily urine and stool samples.
On day 2 and day 9, participants will arrive fasting at the department in the morning and have their anthropometry, breath hydrogen and methane levels measured, and a blood sample will be collected from each participant.
The first visit (day 2) also includes a standardized meal test (rye bread, butter, jam, egg, and yogurt with nuts and berries) and intake of paracetamol (250 mg). Subsequently, the participants will stay at the department for the following 6 hours and have their postprandial breath hydrogen and methane measured and urine collected at specific intervals.
Moreover, a sub-set of the participants will on the first visit (day 2) immediately after intake of the standardized meal swallow a single-use gastrointestinal SmartPill capsule, which will monitor their gastrointestinal pH, transit time, temperature and pressure.
- Conditions
- Diet, Healthy, Metabolic Disease
- Being tested
- 9-days habitual diet
- Keywords
- Microbiome, Metabolomics, Nutrition
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-days habitual dietOther
9-days study with habitual diet including one standardized breakfast on a single day
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal pH vs gut microbial saccharolytic/proteolytic metabolism
We test whether faecal pH is positively associated with microbial-derived proteolytic metabolites (i.e. p-cresol sulfate and phenylacetylglutamine) in urine and negatively associated with microbial-derived saccharolytic metabolites in faeces (i.e. acetate, butyrate and propionate)
Measured: Day 1-9
Secondary outcomes (6)
Abiotic factors vs faecal metagenomic profile
We test whether day-to-day variations in abiotic factors (faecal and/or intestinal pH, faecal redox potential, intestinal transit time and substrate availability) are associated with changes in the faecal microbiome
Measured: Day 1-9
Abiotic factors vs faecal metabolome
We test whether day-to-day variations in abiotic factors (faecal and/or intestinal pH, faecal redox potential, intestinal transit time and substrate availability) are associated with changes in the faecal metabolome
Measured: Day 1-9
Abiotic factors vs urine metabolome
We test whether day-to-day variations in abiotic factors (faecal and/or intestinal pH, faecal redox potential, intestinal transit time and substrate availability) are associated with changes in the urine metabolome
Measured: Day 1-9
Abiotic factors vs blood metabolome
We test whether day-to-day variations in abiotic factors (faecal and/or intestinal pH, faecal redox potential, intestinal transit time and substrate availability) are associated with changes in the blood (serum) metabolome
Measured: Day 2 and 9
Abiotic factors vs microbial-derived metabolites
We test whether day-to-day variations in abiotic factors (faecal and/or intestinal pH, faecal redox potential, intestinal transit time and substrate availability) are associated with changes in diet-derived microbial metabolites in blood/urine/faeces, including short-chain fatty acids, secondary bile acids, phenolic and indolic compounds, branched-chain fatty acids, trimethylamine N-oxide, hippuric acid, urolithin, and enterolactone
Measured: Day 1-9
Faecal metagenomics profile vs metabolome
We test whether day-to-day variations in the microbiome are associated with changes in diet-derived microbial metabolites in blood/urine/faeces, including short-chain fatty acids, secondary bile acids, phenolic and indolic compounds, branched-chain fatty acids, trimethylamine N-oxide, hippuric acid, urolithin, and enterolactone
Measured: Day 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start13 Apr 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, KU Leuven, University of Minnesota
- Responsible party
- Principal investigator, Henrik Munch Roager, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804319
- Sponsor's protocol ID
- M237
- Acronym
- PRIMA
- Status last verified
- Dec 2024
- First submitted
- 4 Mar 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prochazkova N, Laursen MF, La Barbera G, Tsekitsidi E, Jorgensen MS, Rasmussen MA, Raes J, Licht TR, Dragsted LO, Roager HM. Gut physiology and environment explain variations in human gut microbiome composition and metabolism. Nat Microbiol. 2024 Dec;9(12):3210-3225. doi: 10.1038/s41564-024-01856-x. Epub 2024 Nov 27.
PubMed 39604623
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Personalized Dietary Recommendations Based on the Interaction Between Diet, Microbiome and Abiotic Conditions in the Gut
- ClinicalTrials.gov ID
- NCT04804319
- Acronym / sponsor ID
- PRIMA / M237
- Conditions
- Diet, Healthy, Metabolic Disease
- Keywords
- Microbiome, Metabolomics, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Technical University of Denmark, KU Leuven, University of Minnesota
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 18 Mar 2021 (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.
The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.
Detailed description
The study is a 9-day trial including 85 healthy adults in age between 18 and 75. The participants will throughout the trial register their dietary intake, gastrointestinal symptoms including stool frequency and Bristol stool scale, physical activity, and medicine and supplements intake. Participants will on day 3 and day 5, respectively, consume sweet corns to estimate intestinal transit time by the time it takes sweet corn to travel through the gastrointestinal system. Furthermore, the participants will collect daily urine and stool samples.
On day 2 and day 9, participants will arrive fasting at the department in the morning and have their anthropometry, breath hydrogen and methane levels measured, and a blood sample will be collected from each participant.
The first visit (day 2) also includes a standardized meal test (rye bread, butter, jam, egg, and yogurt with nuts and berries) and intake of paracetamol (250 mg). Subsequently, the participants will stay at the department for the following 6 hours and have their postprandial breath hydrogen and methane measured and urine collected at specific intervals.
Moreover, a sub-set of the participants will on the first visit (day 2) immediately after intake of the standardized meal swallow a single-use gastrointestinal SmartPill capsule, which will monitor their gastrointestinal pH, transit time, temperature and pressure.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (8 listed)
- 18.5-30.0 kg/m2 BMI
- Willing to daily collect a urine and stool sample at home and able to store them in their own freezer in a provided containers throughout the 9-days trial
- Willing to eat sweet corn and report corn-intestinal transit time questionnaire
- Willing to record 9 days dietary intake and defecation pattern
- Willing to have blood samples drawn two times
Key exclusion criteria (13 listed)
- Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer´s participation
- Pregnant or lactating women
- Suffering from inflammatory bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO) or inflammatory bowel diseases (IBD)
- Intake of antibiotics, diarrhea inhibitors and laxatives ˂ 1month
- Current chronic or infectious diseases
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 |
|---|---|---|
| 9-days habitual diet9-days study with habitual diet including one standardized breakfast on a single day | Other | – |
Primary outcome
Faecal pH vs gut microbial saccharolytic/proteolytic metabolism
Time frame: Day 1-9
We test whether faecal pH is positively associated with microbial-derived proteolytic metabolites (i.e. p-cresol sulfate and phenylacetylglutamine) in urine and negatively associated with microbial-derived saccharolytic metabolites in faeces (i.e. acetate, butyrate and propionate)
6 secondary outcomes
Abiotic factors vs faecal metagenomic profile
Time frame: Day 1-9
Abiotic factors vs faecal metabolome
Time frame: Day 1-9
Abiotic factors vs urine metabolome
Time frame: Day 1-9
Abiotic factors vs blood metabolome
Time frame: Day 2 and 9
Abiotic factors vs microbial-derived metabolites
Time frame: Day 1-9
Faecal metagenomics profile vs metabolome
Time frame: Day 1-9
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 6 Dec 2024.
- Results publication: PubMed 39604623Prochazkova N, Laursen MF, La Barbera G, Tsekitsidi E, Jorgensen MS, Rasmussen MA, Raes J, Licht TR, Dragsted LO, Roager HM. Gut physiology and environment explain variations in human gut microbiome composition and metabolism. Nat Microbiol. 2024 Dec;9(12):3210-3225. doi: 10.1038/s41564-024-01856-x. Epub 2024 Nov 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Healthy and Metabolic Disease, 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 13 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 6 Dec 2024. 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?
Faecal pH vs gut microbial saccharolytic/proteolytic metabolism (time frame: Day 1-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804319, which also lists 1 linked publication.
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 6 Dec 2024.