Dietary FiberNCT04499183
Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation
A study testing fructo- and galacto-oligosaccharides in people with Dietary Fiber, run by Wageningen University at 1 site in Netherlands.
Trial summary
Nowadays there is a strong interest in optimising human health through manipulation of non-digestible carbohydrates (NDC). NDC can be used as substrates by gut microbiota, which results in NDC degradation, production of fermentation products, such as short-chain fatty acids (SCFA), and a shift in microbiome… 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
- Dietary Fiber
- What is being tested?
- fructo- and galacto-oligosaccharides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Oct 2020to 1 Feb 2021
- 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).
- Having a history of surgical events of the gastro-intestinal tract (e.g. bariatric surgery/gastric bypass surgery)
- Presence of swallowing disorder
- 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.
- Being lactose intolerant
- Follows a vegan diet
Show all 18Show fewer
- Use of antibiotics within 3 months of starting the study or planned during the study
- Use of pro- or prebiotics (e.g. galacto-oligosaccharides, fructo-oligosaccharides)
- Constipation/infrequent bowel movement (less than 3 times defaecation per week)
- Abuse of drugs/alcohol (alcohol: >4 consumptions/day or >21 consumptions/week)
- Smoker
- Having diarrhoea within 1 month prior to the study start
- Personnel of Wageningen University, Division of Human Nutrition, their partner and their first and second degree relatives
- Participation in another biomedical study or other research from the Division of Human Nutrition
- Not willing to be exposed to fluoroscopy
- Having a hemoglobin of <8.5 mmol/L
- Having blood vessels that are too difficult for inserting a cannula
- Not having a general practitioner
Trial locations and contacts
1 site in 1 country.
Guido Hooiveld contact
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University and Research
Wageningen, 6708 WE
Mara van Trijp, MSc, mara.vantrijp@wur.nl
About this study
Official title: A Feasibility Study on Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation
Nowadays there is a strong interest in optimising human health through manipulation of non-digestible carbohydrates (NDC). NDC can be used as substrates by gut microbiota, which results in NDC degradation, production of fermentation products, such as short-chain fatty acids (SCFA), and a shift in microbiome composition and activity. 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, in contrast to the concentrations of SCFA in the proximal colon. Therefore, the influx of short chain fatty acids (SCFA) into the body may be of high importance in improving metabolism. There is a need for more studies in humans to trace the life course of SCFA and their regulatory role in human metabolism. To study this inner world of bacterial products in humans, we will use a nasal-intestine catheter that can be used for delivery of components and sampling chyme in the proximal colon. Before the proposed methodology can be applied in a large intervention study, a small scale feasibility study needs to be performed that addresses colonic placement of the nasal-intestine cathether and colonic sampling of regular and NDC-enriched chyme samples. We will investigate the acute fermentation of fructo- and galacto-oligosaccharides in the proximal colon. Moreover, we will deliver 13C-labelled SCFA via a naso-intestinal catheter to quantify the fluxes of SCFA production, interconversion and uptake by the host. A small-scale, 7-day parallel feasibility trial, N=5 subjects will receive GOS/FOS supplements (mix 1:1 ratio, 15 gram/day), and N=5 other subjects will receive placebo supplements (isocaloric maltodextrin, 12 gram/day). At the last day of the supplementation period, the catheter will be placed, and afterwards participants stay maximum 5 hours in the hospital, to ensure progression of the nose-intestine catheter. After an overnight fast, subjects will visit the hospital again for measurements. Subjects will consume a NDC bolus (200 mL tap water, 5 gram fructo-oligosaccharides, 5 gram galacto-oligosaccharides, non-absorbable marker (PEG-4000). Afterwards, they are not allowed to eat for 6.5 hours. Isotopically 13C-labelled SCFAs will be delivered in the proximal colon. Blood and colonic luminal samples, breath samples, faeces and urine will be collected.
- Conditions
- Dietary Fiber
- Being tested
- fructo- and galacto-oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fructo- and galacto-oligosaccharidesDietary supplement
Also called FOS and GOS
15 gram/day fructo- and galacto-oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| non-digestible carbohydrates | Experimental | fructo- and galacto-oligosaccharides Receives: Dietary Supplement: fructo- and galacto-oligosaccharides |
| placebo | Placebo comparator | maltodextrin 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 carbohydrates
mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen
Measured: Between 0 and 400 minutes
Relative microbiota composition and metabolites
Microbiota and metabolites inside the intestine
Measured: Between 0 and 400 minutes
Concentrations of plasma metabolites
organic acids, amino acids, glucose, cholesterol, fatty acids and bile acids in blood
Measured: Between 0 and 400 minutes
Catheter placement in the colon
To show placement of a naso-intestinal catheter in the proximal colon.
Measured: After 1 week
Volume of colon sample (mL)
To check whether enough material for analysis is obtained if the catheter system takes samples in the proximal colon of participants.
Measured: Between 0 and 400 minutes
Concentrations of SCFAs
(13C isotopic) enrichments of SCFAs inside intestinal lumen
Measured: Between 0 and 400 minutes
Secondary outcomes (3)
Concentrations of urine metabolites
hippurate, di- en tri-methylamine, acetaldehydes, taurine, glycine, glucuronic acid conjugates, and bile acid profiles (conjugates)
Measured: After 0 and 120 minutes
Questionnaires about (dis)comfort of study procedures
Questions about study procedures
Measured: After 1 week
Relative microbiota composition and metabolite concentrations
Microbiota and metabolome in faeces
Measured: After 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start8 Oct 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary FiberStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499183
- Sponsor's protocol ID
- NL74418.081.20
- Status last verified
- Oct 2020
- First submitted
- 26 Feb 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation
- ClinicalTrials.gov ID
- NCT04499183
- Acronym / sponsor ID
- NL74418.081.20
- Conditions
- Dietary Fiber
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 5 Aug 2020 (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.
Nowadays there is a strong interest in optimising human health through manipulation of non-digestible carbohydrates (NDC). NDC can be used as substrates by gut microbiota, which results in NDC degradation, production of fermentation products, such as short-chain fatty acids (SCFA), and a shift in microbiome composition and activity. 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, in contrast to the concentrations of SCFA in the proximal colon. Therefore, the influx of short chain fatty acids (SCFA) into the body may be of high importance in improving metabolism. There is a need for more studies in humans to trace the life course of SCFA and their regulatory role in human metabolism. To study this inner world of bacterial products in humans, we will use a nasal-intestine catheter that can be used for delivery of components and sampling chyme in the proximal colon. Before the proposed methodology can be applied in a large intervention study, a small scale feasibility study needs to be performed that addresses colonic placement of the nasal-intestine cathether and colonic sampling of regular and NDC-enriched chyme samples. We will investigate the acute fermentation of fructo- and galacto-oligosaccharides in the proximal colon. Moreover, we will deliver 13C-labelled SCFA via a naso-intestinal catheter to quantify the fluxes of SCFA production, interconversion and uptake by the host. A small-scale, 7-day parallel feasibility trial, N=5 subjects will receive GOS/FOS supplements (mix 1:1 ratio, 15 gram/day), and N=5 other subjects will receive placebo supplements (isocaloric maltodextrin, 12 gram/day). At the last day of the supplementation period, the catheter will be placed, and afterwards participants stay maximum 5 hours in the hospital, to ensure progression of the nose-intestine catheter. After an overnight fast, subjects will visit the hospital again for measurements. Subjects will consume a NDC bolus (200 mL tap water, 5 gram fructo-oligosaccharides, 5 gram galacto-oligosaccharides, non-absorbable marker (PEG-4000). Afterwards, they are not allowed to eat for 6.5 hours. Isotopically 13C-labelled SCFAs will be delivered in the proximal colon. Blood and colonic luminal samples, breath samples, faeces and urine will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-digestible carbohydrates | Experimental | Dietary Supplement: fructo- and galacto-oligosaccharidesfructo- and galacto-oligosaccharides |
| placebo | Placebo comparator | Dietary Supplement: fructo- and galacto-oligosaccharidesmaltodextrin |
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 (18 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).
- Having a history of surgical events of the gastro-intestinal tract (e.g. bariatric surgery/gastric bypass surgery)
- Presence of swallowing disorder
- 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.
- Being lactose intolerant
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-oligosaccharidesAlso: FOS and GOS15 gram/day fructo- and galacto-oligosaccharides | Dietary supplement | non-digestible carbohydrates, placebo |
Primary outcome
Concentrations of carbohydrates
Time frame: Between 0 and 400 minutes
mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen
Relative microbiota composition and metabolites
Time frame: Between 0 and 400 minutes
Microbiota and metabolites inside the intestine
Concentrations of plasma metabolites
Time frame: Between 0 and 400 minutes
organic acids, amino acids, glucose, cholesterol, fatty acids and bile acids in blood
Catheter placement in the colon
Time frame: After 1 week
To show placement of a naso-intestinal catheter in the proximal colon.
Volume of colon sample (mL)
Time frame: Between 0 and 400 minutes
To check whether enough material for analysis is obtained if the catheter system takes samples in the proximal colon of participants.
Concentrations of SCFAs
Time frame: Between 0 and 400 minutes
(13C isotopic) enrichments of SCFAs inside intestinal lumen
3 secondary outcomes
Concentrations of urine metabolites
Time frame: After 0 and 120 minutes
Questionnaires about (dis)comfort of study procedures
Time frame: After 1 week
Relative microbiota composition and metabolite concentrations
Time frame: After 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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 contact
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 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 18 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: status not confirmed, as of the sponsor's last update on 19 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARA VAN TRIJP (0317 484 067, mara.vantrijp@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of carbohydrates (time frame: Between 0 and 400 minutes). The study lists 6 primary outcomes in all. 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 19 Oct 2020.