Fiber Fermentation, and Short Chain Fatty Acid Kinetics and Utilization Inside the Gut and Systemic Circulation

October 12, 2020 updated by: Wageningen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • Males
  • Age 18-60yrs
  • BMI between 18.5 and 30 kg/m2
  • Regular bowel movement (defaecation on average once a day)
  • Signed informed consent

Exclusion criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
maltodextrin
Dietary supplement: fructo- and galacto-oligosaccharides
15 gram/day fructo- and galacto-oligosaccharides
Other Names:
  • FOS and GOS
Experimental: non-digestible carbohydrates
fructo- and galacto-oligosaccharides
Dietary supplement: fructo- and galacto-oligosaccharides
15 gram/day fructo- and galacto-oligosaccharides
Other Names:
  • FOS and GOS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentrations of carbohydrates
Time Frame: Between 0 and 400 minutes
mono-, di-, tri-, oligo- and polysaccharides in the intestinal lumen
Between 0 and 400 minutes
Relative microbiota composition and metabolites
Time Frame: Between 0 and 400 minutes
Microbiota and metabolites inside the intestine
Between 0 and 400 minutes
Concentrations of plasma metabolites
Time Frame: Between 0 and 400 minutes
organic acids, amino acids, glucose, cholesterol, fatty acids and bile acids in blood
Between 0 and 400 minutes
Catheter placement in the colon
Time Frame: After 1 week
To show placement of a naso-intestinal catheter in the proximal colon.
After 1 week
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.
Between 0 and 400 minutes
Concentrations of SCFAs
Time Frame: Between 0 and 400 minutes
(13C isotopic) enrichments of SCFAs inside intestinal lumen
Between 0 and 400 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentrations of urine metabolites
Time Frame: After 0 and 120 minutes
hippurate, di- en tri-methylamine, acetaldehydes, taurine, glycine, glucuronic acid conjugates, and bile acid profiles (conjugates)
After 0 and 120 minutes
Questionnaires about (dis)comfort of study procedures
Time Frame: After 1 week
Questions about study procedures
After 1 week
Relative microbiota composition and metabolite concentrations
Time Frame: After 1 week
Microbiota and metabolome in faeces
After 1 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentrations of non-digestible markers
Time Frame: Between 0 and 400 minutes
TiO2 and PEG-4000 inside the intestine
Between 0 and 400 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wageningen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL74418.081.20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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