MetabolismNCT04013607
Fiber Fermentation Kinetics Inside the Gut, and Utilization of Bacterial Metabolites
A study testing fructo- and galacto-oligosaccharides in people with Metabolism and Dietary Fiber, run by Wageningen University at 1 site in Netherlands.
Trial summary
In this study, the life course of SCFA and their regulatory role in human metabolism will be traced using a nose-intestine catheter. The investigators have methodological questions: investigate the envisioned kinetic profiles of stable isotope tracers of SCFAs, and to establish the time points of plasma sampling (to… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Dietary Fiber, Intestine
- What is being tested?
- fructo- and galacto-oligosaccharides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jul 2019to 17 Oct 2019
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- Age 18-60yrs
- BMI between 18.5 and 30 kg/m2
- Regular bowel movement (defaecation on average once a day)
- Signed informed consent
Who cannot join
- Having a history of medical or surgical events that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study (e.g. diabetes, cardiovascular disease, gastrointestinal disease, renal failure, cancer, infectious disease, nose/throat).
- Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, analgesics, and herbal remedies during the three (3) weeks prior to study start.
- Carrying a pacemaker or any other (implanted) medical electronic device
- Smoker
- Unstable body weight (weight gain or loss >5kg in the past 3 months prior to the study start)
- Use of antibiotics within 3 months of starting the study or planned during the study
Show all 16Show fewer
- Use of pro- or prebiotics (e.g. galacto-oligosaccharides, fructo-oligosaccharides)
- Constipation/infrequent bowel movement
- Abuse of drugs/alcohol (alcohol: >4 consumptions/day or >21 consumptions/week)
- Participation in another biomedical study
- Having diarrhoea within 2 months prior to the study start
- Personnel of Wageningen University, Division of Human Nutrition, their partner and their first and second degree relatives
- Current participation in other research from the Division of Human Nutrition
- Not willing to have an X-ray
- Having blood vessels that are too difficult for inserting a cannula
- Having a hemoglobin of <8.4 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation
In this study, the life course of SCFA and their regulatory role in human metabolism will be traced using a nose-intestine catheter. The investigators have methodological questions: investigate the envisioned kinetic profiles of stable isotope tracers of SCFAs, and to establish the time points of plasma sampling (to determine systemic availability of SCFAs). The resulting timepoints established in this pilot study will be applied during a future human intervention study.
Read the detailed description
Background: Nowadays there is a strong interest in optimising human health through manipulation of non-digestible carbohydrates (NDC). NDC are fermented by the microbiota, hereby producing fermentation end products, mainly short chain fatty acids (SCFA) acetate, butyrate, and propionate. It is hypothesized that SCFAs mediate parts of the beneficial effects of NDC. In mice, the influx of SCFA into the host correlated strongly with improvements of markers of the metabolic syndrome, whereas concentrations of SCFA in the cecum did not. The production and influx/incorporation of SCFAs in humans will be investigated.
Study design: At day 1 the catheter will be placed. After an overnight fast at day 2, 5 subjects will consume a NDC bolus. Isotopically 13C-labelled SCFAs will be delivered in the cecum. Samples will be taken in the cecum and blood before, and continuously after dispensing the 13C-labelled SCFAs.
Study population: 5 healthy male volunteers (18-60yrs, and BMI between 18.5-30 kg/m2).
Main study parameters/endpoints: (isotopic) enrichments of SCFAs in cecum, and label incorporation in plasma metabolites such as organic acids, glucose, cholesterol, fatty acids.
- Conditions
- Metabolism, Dietary Fiber, Intestine
- Being tested
- fructo- and galacto-oligosaccharides
- Keywords
- short chain fatty acid, dietary fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fructo- and galacto-oligosaccharidesDietary supplement
A NDC drink rich in fructo- and galacto-oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| Fiber drink | Experimental | A drink high in fructo- and galacto-oligosaccharides. Receives: Dietary Supplement: fructo- and galacto-oligosaccharides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of SCFAs
(13C isotopic) enrichments of SCFAs inside intestinal lumen by GC-MS
Measured: Between 0 and 10 hours
Concentrations of plasma metabolites
(13-C isotopic label incorporation) in plasma metabolites by GC-MS
Measured: Between 0 and 10 hours
Secondary outcomes (5)
Concentrations of organic acids
Organic acids measured in plasma and intestinal lumen by GC-MS
Measured: Between 0 and 10 hours
Concentrations of carbohydrates
mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen by GC-MS
Measured: Between 0 and 10 hours
Concentrations of metabolites in urine
bile acids, organic acids, amino acids by GC-MS
Measured: At baseline and after 10 hours
Concentrations of bile acids conjugates
Measured: Between 0 and 10 hours
Relative microbiota composition
in the intestinal lumen, via 16S rRNA sequencing
Measured: Between 0 and 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start8 Jul 2019
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will consume a NDC bolus. When fermentation has started, isotopically 13C-labelled SCFAs will be delivered inside the intestine. Thereafter, production and inter-conversion of SCFAs and breakdown of fiber will be studied in luminal samples. Also blood samples will be taken to study integration of the 13C-label into various metabolic compounds.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Guido Hooiveld, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013607
- Sponsor's protocol ID
- NL69449.081.19
- Status last verified
- Oct 2020
- First submitted
- 23 Apr 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Collected data will be coded
Publications
den Besten G, Havinga R, Bleeker A, Rao S, Gerding A, van Eunen K, Groen AK, Reijngoud DJ, Bakker BM. The short-chain fatty acid uptake fluxes by mice on a guar gum supplemented diet associate with amelioration of major biomarkers of the metabolic syndrome. PLoS One. 2014 Sep 9;9(9):e107392. doi: 10.1371/journal.pone.0107392. eCollection 2014.
PubMed 25203112den Besten G, Lange K, Havinga R, van Dijk TH, Gerding A, van Eunen K, Muller M, Groen AK, Hooiveld GJ, Bakker BM, Reijngoud DJ. Gut-derived short-chain fatty acids are vividly assimilated into host carbohydrates and lipids. Am J Physiol Gastrointest Liver Physiol. 2013 Dec;305(12):G900-10. doi: 10.1152/ajpgi.00265.2013. Epub 2013 Oct 17.
PubMed 24136789
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation
- ClinicalTrials.gov ID
- NCT04013607
- Acronym / sponsor ID
- NL69449.081.19
- Conditions
- Metabolism, Dietary Fiber, Intestine
- Keywords
- short chain fatty acid, dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 10 Jul 2019 (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.
In this study, the life course of SCFA and their regulatory role in human metabolism will be traced using a nose-intestine catheter. The investigators have methodological questions: investigate the envisioned kinetic profiles of stable isotope tracers of SCFAs, and to establish the time points of plasma sampling (to determine systemic availability of SCFAs). The resulting timepoints established in this pilot study will be applied during a future human intervention study.
Detailed description
Background: Nowadays there is a strong interest in optimising human health through manipulation of non-digestible carbohydrates (NDC). NDC are fermented by the microbiota, hereby producing fermentation end products, mainly short chain fatty acids (SCFA) acetate, butyrate, and propionate. It is hypothesized that SCFAs mediate parts of the beneficial effects of NDC. In mice, the influx of SCFA into the host correlated strongly with improvements of markers of the metabolic syndrome, whereas concentrations of SCFA in the cecum did not. The production and influx/incorporation of SCFAs in humans will be investigated.
Study design: At day 1 the catheter will be placed. After an overnight fast at day 2, 5 subjects will consume a NDC bolus. Isotopically 13C-labelled SCFAs will be delivered in the cecum. Samples will be taken in the cecum and blood before, and continuously after dispensing the 13C-labelled SCFAs.
Study population: 5 healthy male volunteers (18-60yrs, and BMI between 18.5-30 kg/m2).
Main study parameters/endpoints: (isotopic) enrichments of SCFAs in cecum, and label incorporation in plasma metabolites such as organic acids, glucose, cholesterol, fatty acids.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will consume a NDC bolus. When fermentation has started, isotopically 13C-labelled SCFAs will be delivered inside the intestine. Thereafter, production and inter-conversion of SCFAs and breakdown of fiber will be studied in luminal samples. Also blood samples will be taken to study integration of the 13C-label into various metabolic compounds.
| Arm | Type | Receives |
|---|---|---|
| Fiber drink | Experimental | Dietary Supplement: fructo- and galacto-oligosaccharidesA drink high in fructo- and galacto-oligosaccharides. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males
- Age 18-60yrs
- BMI between 18.5 and 30 kg/m2
- Regular bowel movement (defaecation on average once a day)
- Signed informed consent
Key exclusion criteria (16 listed)
- Having a history of medical or surgical events that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study (e.g. diabetes, cardiovascular disease, gastrointestinal disease, renal failure, cancer, infectious disease, nose/throat).
- Use of any prescribed or non-prescribed medication (other than paracetamol) including antacids, analgesics, and herbal remedies during the three (3) weeks prior to study start.
- Carrying a pacemaker or any other (implanted) medical electronic device
- Smoker
- Unstable body weight (weight gain or loss >5kg in the past 3 months prior to the study start)
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 |
|---|---|---|
| fructo- and galacto-oligosaccharidesA NDC drink rich in fructo- and galacto-oligosaccharides | Dietary supplement | Fiber drink |
Primary outcome
Concentrations of SCFAs
Time frame: Between 0 and 10 hours
(13C isotopic) enrichments of SCFAs inside intestinal lumen by GC-MS
Concentrations of plasma metabolites
Time frame: Between 0 and 10 hours
(13-C isotopic label incorporation) in plasma metabolites by GC-MS
5 secondary outcomes
Concentrations of organic acids
Time frame: Between 0 and 10 hours
Concentrations of carbohydrates
Time frame: Between 0 and 10 hours
Concentrations of metabolites in urine
Time frame: At baseline and after 10 hours
Concentrations of bile acids conjugates
Time frame: Between 0 and 10 hours
Relative microbiota composition
Time frame: Between 0 and 10 hours
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 14 Oct 2020.
- Background: PubMed 25203112den Besten G, Havinga R, Bleeker A, Rao S, Gerding A, van Eunen K, Groen AK, Reijngoud DJ, Bakker BM. The short-chain fatty acid uptake fluxes by mice on a guar gum supplemented diet associate with amelioration of major biomarkers of the metabolic syndrome. PLoS One. 2014 Sep 9;9(9):e107392. doi: 10.1371/journal.pone.0107392. eCollection 2014.
- Background: PubMed 24136789den Besten G, Lange K, Havinga R, van Dijk TH, Gerding A, van Eunen K, Muller M, Groen AK, Hooiveld GJ, Bakker BM, Reijngoud DJ. Gut-derived short-chain fatty acids are vividly assimilated into host carbohydrates and lipids. Am J Physiol Gastrointest Liver Physiol. 2013 Dec;305(12):G900-10. doi: 10.1152/ajpgi.00265.2013. Epub 2013 Oct 17.
- Individual participant dataSharing planned: Undecided. Collected data will be coded
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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.
Guido Hooiveld, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fructo- and galacto-oligosaccharides in people with Metabolism and Dietary Fiber, run by Wageningen University at 1 site in Netherlands.
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 5 inclusion and 16 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 14 Oct 2020. 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 Netherlands. 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?
Concentrations of SCFAs (time frame: Between 0 and 10 hours). The study lists 2 primary outcomes in all. 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 NCT04013607, which also lists 2 linked publications.
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 14 Oct 2020.